Methods for using an electrical dermal patch in a manner that reduces adverse patient reactions

ABSTRACT

The disclosed electrical stimulation system generates interventions to assist patients in complying with a diet. The wearable device includes a microprocessor, electrical stimulator and at least one electrode configured to deliver electrical stimulation to the epidermis, through a range of 0.1 mm to 10 mm or a range of 0.1 mm to 20 mm of the dermis, of a T2 dermatome to a T12 dermatome or meridian of the patient, a C5 to a T1 dermatome across the hand and/or arm, and/or the upper chest regions. The device is adapted to provide electrical stimulation as per stimulation protocols and to communicate wirelessly with a companion control device configured to monitor and record appetite patterns of the patient and generate interventions. The control device is also configured to monitor, record, and modify stimulation parameters of the stimulation protocols.

CROSS-REFERENCE

The present application relies on, for priority, the following U.S.Provisional Patent Applications:

U.S. Patent Provisional Application No. 62/532,317, entitled “Systemsand Methods for Engaging In Eating Interventions and Appetite ModulationBased on Closed Loop Glucose Monitoring” and filed on Jul. 13, 2017; and

U.S. Patent Provisional Application No. 62/413,213, entitled “Systemsand Methods for Enabling Appetite Modulation and/or Improving DietaryCompliance Using an Electro-Dermal Patch” and filed on Oct. 26, 2016.

The present application is also a continuation-in-part application ofU.S. patent application Ser. No. 15/702,676, entitled “Systems andMethods for Using Transcutaneous Electrical Stimulation to EnableDietary Interventions”, and filed on Sep. 12, 2017, which relies on, forpriority, the following U.S. Provisional Patent Applications:

U.S. Patent Provisional Application No. 62/532,317, entitled “Systemsand Methods for Engaging In Eating Interventions and Appetite ModulationBased on Closed Loop Glucose Monitoring” and filed on Jul. 13, 2017; and

U.S. Patent Provisional Application No. 62/413,213, entitled “Systemsand Methods for Enabling Appetite Modulation and/or Improving DietaryCompliance Using an Electro-Dermal Patch” and filed on Oct. 26, 2016;and

U.S. Patent Provisional Application No. 62/393,486, entitled “Systemsand Methods for Enabling Appetite Modulation and/or Improving DietaryCompliance Using an Electro-Dermal Patch” and filed on Sep. 12, 2016.

U.S. patent application Ser. No. 15/702,676 is also acontinuation-in-part application of U.S. patent application Ser. No.15/590,750, entitled “Systems and Methods for Achieving Weight LossUsing a Transcutaneous Electro-Dermal Patch” and filed on May 9, 2017,which relies on, for priority, the following U.S. Provisional PatentApplications:

U.S. Patent Provisional Application No. 62/413,213, entitled “Systemsand Methods for Enabling Appetite Modulation and/or Improving DietaryCompliance Using an Electro-Dermal Patch” and filed on Oct. 26, 2016;

U.S. Patent Provisional Application No. 62/393,486, entitled “Systemsand Methods for Enabling Appetite Modulation and/or Improving DietaryCompliance Using an Electro-Dermal Patch” and filed on Sep. 12, 2016;

U.S. Patent Provisional Application No. 62/378,393, entitled “Systemsand Methods for Enabling Appetite Modulation and/or Improving DietaryCompliance Using an Electro-Dermal Patch” and filed on Aug. 23, 2016;and

U.S. Patent Provisional Application No. 62/341,917, entitled “Systemsand Methods for Enabling Appetite Modulation and/or Improving DietaryCompliance Using an Electro-Dermal Patch” and filed on May 26, 2016.

U.S. patent application Ser. No. 15/590,750 is also acontinuation-in-part application of U.S. patent application Ser. No.15/370,944, entitled “Systems and Methods for Increasing A Delay in theGastric Emptying Time for a Patient Using a TranscutaneousElectro-Dermal Patch” and filed on Dec. 6, 2016, which relies on, forpriority, the following U.S. Provisional Patent Applications:

U.S. Patent Provisional Application No. 62/413,213, entitled “Systemsand Methods for Enabling Appetite Modulation and/or Improving DietaryCompliance Using an Electro-Dermal Patch” and filed on Oct. 26, 2016;

U.S. Patent Provisional Application No. 62/393,486, entitled “Systemsand Methods for Enabling Appetite Modulation and/or Improving DietaryCompliance Using an Electro-Dermal Patch” and filed on Sep. 12, 2016;

U.S. Patent Provisional Application No. 62/378,393, entitled “Systemsand Methods for Enabling Appetite Modulation and/or Improving DietaryCompliance Using an Electro-Dermal Patch” and filed on Aug. 23, 2016;

U.S. Patent Provisional Application No. 62/341,917, entitled “Systemsand Methods for Enabling Appetite Modulation and/or Improving DietaryCompliance Using an Electro-Dermal Patch” and filed on May 26, 2016; and

U.S. Patent Provisional Application No. 62/326,541, entitled “Systemsand Methods for Enabling Appetite Modulation and/or Improving DietaryCompliance Using an Electro-Dermal Patch” and filed on Apr. 22, 2016.

U.S. patent application Ser. No. 15/370,944 is also acontinuation-in-part application of U.S. patent application Ser. No.15/052,791, entitled “Systems and Methods for Enabling AppetiteModulation and/or Improving Dietary Compliance Using an Electro-DermalPatch” and filed on Feb. 24, 2016.

U.S. patent application Ser. No. 15/370,944 is also acontinuation-in-part application of U.S. patent application Ser. No.15/052,784, entitled “Systems and Methods for Enabling AppetiteModulation and/or Improving Dietary Compliance Using an Electro-DermalPatch” and filed on Feb. 24, 2016.

U.S. patent application Ser. No. 15/370,944 is also acontinuation-in-part application of U.S. patent application Ser. No.15/204,752, entitled “Systems and Method for Enabling AppetiteModulation and/or Improving Dietary Compliance Using PercutaneousElectrical Neurostimulation”, filed on Jul. 7, 2016, which, in turn, isa continuation-in-part of both U.S. patent application Ser. No.15/052,791, entitled “Systems and Methods for Enabling AppetiteModulation and/or Improving Dietary Compliance Using an Electro-DermalPatch” and filed on Feb. 24, 2016 and U.S. patent application Ser. No.15/052,784, entitled “Systems and Methods for Enabling AppetiteModulation and/or Improving Dietary Compliance Using an Electro-DermalPatch” and filed on Feb. 24, 2016.

U.S. patent application Ser. No. 15/052,791; U.S. patent applicationSer. No. 15/052,784 and thus, U.S. patent application Ser. No.15/204,752 (as a CIP to the '791 and '784 applications) rely on thefollowing applications, for priority:

U.S. Patent Provisional Application No. 62/248,059, entitled “Systemsand Methods for Enabling Pain Management Using an Electro-Dermal Patch”and filed on Oct. 29, 2015;

U.S. Patent Provisional Application No. 62/247,113, entitled “Systemsand Methods for Enabling Appetite Modulation Using an Electro-DermalPatch” and filed on Oct. 27, 2015;

U.S. Patent Provisional Application No. 62/246,526, entitled “Systemsand Methods for Enabling Appetite Modulation Using an Electro-DermalPatch” and filed on Oct. 26, 2015;

U.S. Patent Provisional Application No. 62/242,957, entitled “Systemsand Methods for Enabling Appetite Modulation Using an Electro-DermalPatch” and filed on Oct. 16, 2015;

U.S. Patent Provisional Application No. 62/242,944, entitled “Systemsand Methods for Enabling Appetite Modulation Using an Electro-DermalPatch” and filed on Oct. 16, 2015;

U.S. Patent Provisional Application No. 62/240,808, entitled “Systemsand Methods for Enabling Appetite Modulation Using an Electro-DermalPatch” and filed on Oct. 13, 2015;

U.S. Patent Provisional Application No. 62/237,356, entitled “Systemsand Methods for Enabling Appetite Modulation Using TranscutaneousElectrical Neurostimulation” and filed on Oct. 5, 2015;

U.S. Patent Provisional Application No. 62/189,805, entitled “DermatomeStimulation System” and filed on Jul. 8, 2015;

U.S. Patent Provisional Application No. 62/189,800, entitled “DermatomeStimulation Method” and filed on Jul. 8, 2015;

U.S. Patent Provisional Application No. 62/161,362, entitled “DermatomeStimulation Method” and filed on May 14, 2015;

U.S. Patent Provisional Application No. 62/161,353, entitled “DermatomeStimulation System” and filed on May 14, 2015;

U.S. Patent Provisional Application No. 62/141,333, entitled “DermatomeStimulation Method” and filed on Apr. 1, 2015;

U.S. Patent Provisional Application No. 62/141,328, entitled “DermatomeStimulation System” and filed on Apr. 1, 2015;

U.S. Patent Provisional Application No. 62/133,530, entitled “DermatomeStimulation Method” and filed on Mar. 16, 2015;

U.S. Patent Provisional Application No. 62/133,526, entitled “DermatomeStimulation System” and filed on Mar. 16, 2015;

U.S. Patent Provisional Application No. 62/120,082, entitled “DermatomeStimulation Methods” and filed on Feb. 24, 2015; and

U.S. Patent Provisional Application No. 62/120,067, entitled “DermatomeStimulation System” and filed on Feb. 24, 2015.

The present application also relates to International Application NumberPCT/US16/19416, entitled “Systems and Methods for Enabling AppetiteModulation and/or Improving Dietary Compliance Using an Electro-DermalPatch” and filed on Feb. 24, 2016.

All of the above-mentioned applications are herein incorporated byreference in their entirety.

FIELD

The present specification relates generally to systems and methods ofgenerating appropriate dietary interventions by providing transcutaneouselectrical stimulation using an electrical dermal patch that isoptimized for long term wearability. The disclosed systems deliverelectrical stimulation to a predetermined area of the user's anatomy ina manner that is convenient, easy to use, and amenable to increasedpatient compliance. More particularly, the present specification relatesto electrical stimulation devices comprising low profile, wearable,disposable skin patches that are easy to self-administer, programmableand monitorable using a mobile handheld device, and programmed tostimulate a patient's nerves from the external surface of the patient'sepidermal layer or epidermis in a manner that decreases appetite andhunger, avoids nausea, minimizes habituation and enables increasedcompliance with a dietary regimen. The present specification furtherrelates to a low profile, wearable, disposable skin patch that iscapable of integrating with, and being controlled by, a plurality ofdifferent hardware devices or software applications depending on thetype, extent, nature and scope of the nature and degree of dietarycompliance required and the amount of weight loss desired and/or theneed for long term weight maintenance.

BACKGROUND

Being obese, or overweight, is a condition that often results from animbalance between food intake and caloric expenditure. Excessive weightincreases the likelihood of several additional risks includingcardiovascular complications (such as hypertension and hyperlipidemia),gallbladder disease, metabolic syndrome, cancer, polycystic ovarydisease, pregnancy-related complications, arthritis-relatedcomplications and other orthopedic complications caused by stress onbody joints. Obesity is also thought to be a primary cause of type 2diabetes (T2DM) in many ethnicities.

Certain methods and systems of using electrical stimulation to modulatefood intake have been disclosed in the art. In U.S. Pat. Nos. 8,538,532and 8,185,206, serosal electrodes are surgically implanted in thegastrointestinal tract to cause impaired gastric myoelectric activity,retrograde propagation of gastric slow waves, suppression of antralcontractions, and delayed gastric emptying. Gastric dysrhythmia has beenshown to be associated with gastrointestinal symptoms and delayedgastric emptying which, in turn, is associated with weight loss. Theelectrical stimulation therapy is configured to cause at least partialgastric distention, thereby inducing a sensation of fullness anddiscouraging excessive food intake by the patient. The electricalstimulation therapy is delivered to the gastrointestinal tract of thepatient by electrodes deployed by one or more implantable leads coupledto an electrical stimulator. The stimulation protocols require asignificant amount of energy and are expressly designed to causemuscular contractions or otherwise electrically dysregulate gastric slowwaves.

While potentially effective, such therapies require a medicalprofessional to surgically place the device and/or administer thetherapy and require a substantial amount of energy to cause muscularcontractions or actual impairment of gastric slow waves. The patientmust visit the medical professional at the onset of treatment to havethe device placed and then periodically thereafter to have the therapyadministered and/or device programming modified. The requirement forsuch frequent doctor visits is inconvenient for most patients and canhave a detrimental effect on patient compliance.

With respect to prior art approaches that use electrical, externalstimulation to suppress appetite, they do not have a combination of thefollowing characteristics effective to enable a patient to independentlyadminister the device and accompanying therapies: small footprint;administration by the patient; real-time or near real-time feedback fromthe patient (e.g. food intake, exercise, hunger) or from wearabledevices, for example, a device, with physiological sensors, configuredto be worn on the human body, such as around the wrist, in order tomonitor, acquire, record, and/or transmit the physiological data; theability to stimulate multiple times per day or week; daily, oron-demand, feedback from the device to the patient with respect todietary compliance, exercise, calories burned; storage of stimulationparameters and other real-time inputs; effective dietary interventions,and an electrical stimulation profile and a footprint conducive to longterm wearability. In addition, prior art therapies which have somedegree of flexibility include an electrode which must be tethered viacables to a control or power box. Prior art therapies which are wirelessare typically bulky, inflexible, and not amenable to being worn for longperiods of time.

Because successful weight loss is, in the end, a matter of achieving ahigh degree of compliance with a dietary regimen, it is absolutelycritical for a successful device to go beyond mere stimulation andcombine wearability, physical comfort, ease of use, accurateinterventions and integration of numerous data sources to provide aholistic and real-time view into a person's dietary compliance, inaddition to effectively modulating the individual's gastric volume, rateof gastric emptying, appetite, hunger, satiety level, satiation level,and/or fullness.

Therefore, there is a need for a low profile, long lasting electricalneuro-stimulation device which is programmable, and is designed to beworn over a longer period of time. There is also a need for a devicethat can effectively integrate appetite management data withconventional weight management information, such as caloric expenditureand consumption.

There is a need for an electrical neuro-stimulation device which iswearable and can be controlled, programmed, and self-administered by thepatient, thereby enabling greater patient independence. There is also aneed for an electrical neuro-stimulation device which includes real-timeor near real-time feedback from patient parameters including, but notlimited to, exercise, diet, hunger, appetite, well-being and which willbe able to obtain real-time or near real-time feedback from otherwearable devices, for example, a device, with physiological sensors,configured to be worn on the human body, such as around the wrist, inorder to monitor, acquire, record, and/or transmit the physiologicaldata, allowing for frequent adjustability and customization of therapyto suppress appetite and therefore treat conditions of obesity,over-weight, eating disorders, metabolic syndrome. There is a need foran electro-stimulation device configured to intelligently trigger andinitiate stimulation automatically and without on-going management by auser. There is a need for an electrical neuro-stimulation device havingthe ability to stimulate multiple times per day or per week,accelerating treatment effect and efficacy. There is a need for anelectrical neuro-stimulation device which provides daily feedback fromthe device to the patient on such parameters as dietary compliance, andcalories burned.

In addition, there is a need for an electrical neuro-stimulation devicecapable of storing stimulation parameters and other real-time inputs,such as diary and exercise monitoring, to provide a physician and thepatient with real-time records and treatment profiles. Inputs from theelectrical neuro-stimulation device and from other sources ofinformation, for example, a device, with physiological sensors,configured to be worn on the human body, such as around the wrist, inorder to monitor, acquire, record, and/or transmit the physiologicaldata would be stored.

There is also a need to allow physicians to be able to flexibly programan electrical neuro-stimulation device and still direct the patient,allowing the patient to adjust device parameters (for greater patientindependence) but within restricted bounds or predetermined parameters.

There is also a need for an electrical neuro-stimulation device whichtargets a rate of appetite or hunger suppression, does not requireimplantation, and does not require wires or remote electrodes to providestimulation. There is a need for an electrical neuro-stimulation devicewhich is remotely programmable, yet wireless, can flex at any pointalong its body, is waterproof, and is configured for extended orpermanent wearability. There is also a need for a patient-administered,wearable electrical neuro-stimulation device directed toward suppressingpost-prandial glucose levels and effectively modulating a plurality ofhormones and microbiota related to gastrointestinal functionality. Thereis a need for an electrical neuro-stimulation device having a size,shape, and weight, and being composed of materials that effectivelyallow the device to be wearable. Such a device would eliminate the needfor stimulation parameters requiring large power needs (which would makewearability impractical or impossible). There is also a need for anelectrical neuro-stimulation device which is controllable by a companiondevice (such as a smartphone) and includes no visible or tactile userinterface on the stimulation device itself. There is a need for anelectrical neuro-stimulation device having unique electrical stimulationand footprint, based on electrode design and stimulation parameters,which would allow users to comfortably wear the device.

There is also a need for a holistic approach to managing a patient'scaloric consumption and expenditure profile. Conventional approachesfocus on caloric intake but do not analyze, monitor, or otherwise gatherdata on the important precursor to caloric intake, namely appetite orhunger levels. There are untapped benefits to integrating data relatingto the appetite, hunger and/or craving levels, active suppression orcontrol over appetite, caloric intake, weight gain, and caloricexpenditure. These and other benefits shall be described in relation tothe detailed description and figures.

SUMMARY

The following embodiments and aspects thereof are described andillustrated in conjunction with systems, tools and methods, which aremeant to be exemplary and illustrative, and not limiting in scope. Thepresent application discloses numerous embodiments.

The device may be used to treat a condition including any one ofobesity, excess weight, eating disorders, metabolic syndrome anddiabetes. In accordance with various aspects of the presentspecification, the electro-dermal patch device enables treating peoplewith BMI (Body Mass Index) of 25 or greater (overweight being 25-30,obese being 30 and above, and morbid obesity being above 35).

The present specification discloses an electrical dermal patch adaptedto be continuously worn by a patient for at least 24 hours, a housingcomprising a controller in electrical communication with a pulsegenerator; and at least two electrodes adapted to be adhered to thepatient's skin and in electrical communication with the pulse generator,wherein the controller comprises programmatic instructions that, whenexecuted and transmitted to the pulse generator, cause the pulsegenerator to generate and transmit to the at least two electrodes afirst electrical stimulation pulse and a second electrical stimulationpulse, wherein the first electrical pulse is defined by a first phasehaving a first polarity and a second phase having a second polarity thatis opposite the first polarity, wherein the second electrical pulsefollows the first electrical pulse and is defined by a third phasehaving a third polarity and a fourth phase having a fourth polarity thatis opposite the third polarity, and wherein the second polarity is equalto the third polarity.

Optionally, the second electrical pulse follows the first electricalpulse after a predetermined wait period.

Optionally, the first polarity is positive, the second polarity isnegative, the third polarity is negative, and the fourth polarity ispositive.

Optionally, the first polarity is negative, the second polarity ispositive, the third polarity is positive, and the fourth polarity isnegative.

Optionally, each of the at least two electrodes comprise ahypoallergenic conductive gel with at least one adhesive surface.

Optionally, the electrode does not comprise imidazolidinyl urea ordiazolidinyl urea.

Optionally, the electrode comprises carboxymethylcellulose polymer andpropylene glycol.

Optionally, the at least one adhesive surface is adapted to adhere tothe patient's skin and have a peel strength in a range of 1.0 to 2.1newtons.

Optionally, the at least one adhesive surface is adapted to adhere tothe patient's skin and have a total skin contact surface area in a rangeof 2 cm² to 4 cm².

Optionally, the at least two electrodes are positioned in a same planeparallel to the patient's skin and separated by a distance of 0.05 cm²to 0.4 cm².

Optionally, an amplitude of the first phase, the second phase, the thirdphase, and the fourth phase are equal and a pulse width of the firstphase, the second phase, the third phase, and the fourth phase areequal.

Optionally, the predefined time interval is in a range of 1 minute to 10minutes.

Optionally, an amplitude of the first phase and the fourth phase areequal, wherein a pulse width of the first phase and the fourth phase areequal, an amplitude of the second phase and the third phase are equal,wherein a pulse width of the second phase and the third phase are equal,and wherein at least one of the amplitude and the pulse width of thefirst phase is different from the amplitude and pulse width of thesecond phase.

Optionally, the first phase is defined by a waveform characterized by afirst period and a second period, wherein the first period comprises afirst 10 μs of the waveform and the second period comprises a remainderof the waveform and wherein said waveform is defined by a maximumamplitude during the first period and an amplitude less than saidmaximum amplitude during the second period.

Optionally, the maximum amplitude is in a range of 20 to 40 mA.

Optionally, the maximum amplitude is in a range of 20 to 40 mA and anaverage amplitude across said first period and second period is in arange of 10 mA to 20 mA.

Optionally, the pulse generator has a maximum compliance voltage in arange of 40 volts to 60 volts.

Optionally, at least one of the first phase, second phase, third phase,and fourth phase is defined by a waveform characterized by a firstperiod, a second period, and a third period, wherein the first periodcomprises at least a portion of 0 to 10 μs of the waveform, the secondperiod comprises at least a portion of 10 μs to 100 μs of the waveform,and the third period comprises at least a portion of 100 μs to 200 μs ofthe waveform, wherein the first period is defined by a maximum amplitudeand the second and third periods are defined by a remainder amplitudeless than said maximum amplitude.

Optionally, the maximum amplitude is in a range of 20 mA to 40 mA.

Optionally, in the second period, a decay of the remainder amplitude isdefined by a first negative slope having a first magnitude and, in thethird period, a decay of said remainder amplitude is defined by a secondnegative slope having a second magnitude, wherein the first magnitude isless than the second magnitude.

Optionally, an average of the maximum amplitude and the remainderamplitude is in a range of 10 mA to 20 mA.

In some embodiments, the present specification discloses an electricaldermal patch adapted to be continuously worn by a patient for at least 1day, a housing comprising a controller in electrical communication witha pulse generator; and two electrodes adapted to be adhered to thepatient's skin, positioned in a same plane parallel to the patient'sskin, separated by a distance of 0.05 cm² to 0.4 cm². and in electricalcommunication with the pulse generator, wherein the controller comprisesprogrammatic instructions that, when executed and transmitted to thepulse generator, cause the pulse generator to generate and transmit tothe at least two electrodes a first set of electrical stimulation pulsesand a second set of electrical stimulation pulses and wherein each ofthe at least two electrodes comprise a hypoallergenic conductive gelwith at least one adhesive surface, wherein the hypoallergenicconductive gel does not comprise imidazolidinyl urea or diazolidinylurea and wherein the at least one adhesive surface is adapted to adhereto the patient's skin and have a total skin contact surface area in arange of 2 cm² to 4 cm².

Optionally, the electrode comprises carboxymethylcellulose polymer andpropylene glycol.

Optionally, each of the electrical stimulation pulses is defined by acharged balanced biphasic waveform and wherein the first set ofelectrical stimulation pulses and second set of electrical stimulationpulses are separated by a predefined time interval.

Optionally, the predefined time interval is randomized and is at least 1minute long.

Optionally, the pulse generator has a maximum compliance voltage in arange of 40 volts to 60 volts.

Optionally, each of the electrical stimulation pulses is defined by awaveform characterized by a first period, a second period, and a thirdperiod, wherein the first period comprises at least a portion of 0 to 10μs of the waveform, the second period comprises at least a portion of 10μs to 100 μs of the waveform, and the third period comprises at least aportion of 100 μs to 200 μs of the waveform, wherein the first period isdefined by a maximum amplitude and the second and third periods aredefined by a remainder amplitude less than said maximum amplitude.

Optionally, the maximum amplitude of the electrical dermal patch is in arange of 20 mA to 40 mA.

Optionally, in the second period, a decay of said remainder amplitude isdefined by a first negative slope having a first magnitude and, in thethird period, a decay of said remainder amplitude is defined by a secondnegative slope having a second magnitude, wherein the first magnitude isless than the second magnitude.

Optionally, an average of the maximum amplitude and the remainderamplitude is in a range of 10 mA to 20 mA.

In some embodiments, the present specification discloses a method ofusing the electrical dermal patch of claim 1 comprising: programming thecontroller such that each of the electrical stimulation pulses comprisesa pulse width in a range of 10 μsec to 10 msec, a pulse amplitude in arange of 100 μA to 100 mA, and a pulse frequency in a range of 1 Hz and100 Hz; and determining if the patient experiences a change in appetiteas a result of an application of said first set of electricalstimulation pulses or said second set of electrical stimulation pulsesto the patient's skin, wherein the patient does not experience erythema,scaling, pruritus, folliculitis, or intertrigo at a point where said twoelectrodes adhere to the patient's skin.

Optionally, the method further comprises programming the controller suchthat each of the electrical stimulation pulses comprises a pulse widthin a range of 10 μsec to 10 msec, a pulse amplitude in a range of 100 μAto 100 mA, and a pulse frequency in a range of 1 Hz and 100 Hz; anddetermining if the patient experiences a change in appetite as a resultof an application of said first set of electrical stimulation pulses orsaid second set of electrical stimulation pulses to the patient's skin,wherein the patient does not experience erythema, scaling, pruritus,folliculitis, or intertrigo at a point where said two electrodes adhereto the patient's skin.

The present specification discloses a system to generate real-timeinterventions in response to a patient's degree of appetite, comprising:an electrical dermal patch comprising: a housing; a controllerpositioned within the housing; at least one electrode positioned inphysical communication with the housing and adapted to be in electricalcontact with the patient's skin; and, a pulse generator positionedwithin the housing and in electrical communication with the controllerand said at least one electrode, wherein the pulse generator isconfigured to generate a plurality of stimulation sessions comprising aplurality of electrical pulses defined by stimulation parameters andwherein said stimulation parameters comprise a first pulse width in arange of 10 μsec to 10 msec, a first pulse amplitude in a range of 100μA to 100 mA, and a first pulse frequency in a range of 1 Hz and 100 Hz;a first plurality of programmatic instructions stored in a non-transientmemory in a client device separate from the electrical dermal patch,wherein, when executed, said first plurality of programmaticinstructions is adapted to cause the client device to generate a promptto the patient to input data indicative of the patient's degree ofappetite via a microphone or a display of said client device; a secondplurality of programmatic instructions stored in a non-transient memoryin the client device or another device separate from the electricaldermal patch, wherein, when executed, said second plurality ofprogrammatic instructions determines an appetite pattern of the patientbased upon said inputted data; and a third plurality of programmaticinstructions stored in a non-transient memory in the client device oranother device separate from the electrical dermal patch, wherein, whenexecuted, said third plurality of programmatic instructions determinesan intervention and generates said intervention based on the appetitepattern.

Optionally, said intervention is causing at least one of a text-basedmessage, video message, audio message, or graphic message to betransmitted to the patient via the client device.

Optionally, said intervention is modifying the stimulation parameterssuch that at least one of a pulse width is different than the firstpulse width, a pulse amplitude is different than the first pulseamplitude, and a pulse frequency is different than the first pulsefrequency.

Optionally, said second plurality of programmatic instructionsdetermines an appetite pattern of the patient based upon the inputteddata by determining a time window associated with each of the inputteddata and, for each time window, determining if value ranges of allinputted data associated with the time window are within a predefinedrange around a value to constitute a pattern. The time window may be ina range of 1 to 3 hours.

Optionally, said second plurality of programmatic instructionsdetermines an appetite pattern of the patient based upon the inputteddata by determining a time window associated with each of the inputteddata and, for each time window, determining if value ranges of allinputted data associated with the time window are not within apredefined range around a value to constitute a pattern.

Optionally, said second plurality of programmatic instructionsdetermines an appetite pattern of the patient based upon the inputteddata by determining a time window associated with each of the inputteddata and, for each time window, determining if a number of individualinputted data values associated with the time window are sufficientlylarge to constitute a pattern.

Optionally, said second plurality of programmatic instructionsdetermines an appetite pattern of the patient based upon the inputteddata by determining a time window associated with each of the inputteddata and, for each time window, determining if a number of individualinputted data values associated with the time window are too low toconstitute a pattern. The time window may be in a range of 1 to 3 hours.

Optionally, the prompt is in a form of at least one of an audio message,video message, text message, and graphical message.

Optionally, the first plurality of programmatic instructions is adaptedto cause the client device to generate the prompt at a first rate for afirst time window and at a second rate after said first time window,wherein the second rate is less than the first rate. Optionally, thefirst rate is in a range of once per day to twenty four times per dayand the first time window is in a range of 1 day to 1 month. Optionally,the first plurality of programmatic instructions is adapted to providethe patient with an option, via the display of the client device, tomodify the first rate.

Optionally, said third plurality of programmatic instructions determinesthe intervention by processing the appetite pattern indicative of thepatient's degree of appetite to determine if the patient's degree ofappetite is expected to be greater than or less than a first thresholdvalue at a future time window. Optionally, if the patient's degree ofappetite is expected to be less than the first threshold value at thefuture time window, said third plurality of programmatic instructionsdoes not generate the intervention during the future time window.Optionally, if the patient's degree of appetite is expected to begreater than the first threshold value at the future time window, saidthird plurality of programmatic instructions generates the interventionduring the future time window. The intervention may cause at least oneof a text-based message, video message, audio message, or graphicmessage to be transmitted to the patient via the client device. Theintervention may modify the stimulation parameters such that at leastone of a pulse width is different than the first pulse width, a pulseamplitude is different than the first pulse amplitude, and a pulsefrequency is different than the first pulse frequency.

Optionally, when executed, the first plurality of programmaticinstructions generates the prompt in a form of a visual analog scale andcauses said prompt to be displayed on the client device, wherein eachvalue along said visual analog scale is representative of a differentdegree of appetite. The visual analog scale may be a light bar having asliding scale, wherein a first end of the sliding scale is indicative ofa low degree of appetite and a second end of the sliding scale isindicative of a high degree of appetite.

Optionally, when executed, the first plurality of programmaticinstructions generates the prompt in a form of a plurality of icons andwherein each of said plurality of icons is representative of a differentdegree of appetite.

Optionally, when executed, the first plurality of programmaticinstructions generates the prompt in a form of auditory inquires andcauses said auditory inquiries to be played via a speaker of said clientdevice.

Optionally, when executed, the third plurality of programmaticinstructions receives the appetite pattern of the patient and causessaid appetite pattern to be displayed on the client device, wherein theappetite pattern is in a form of a graph having a time of day on a firstaxis, a calendar day on a second axis, and an icon representing a degreeof the patient's appetite plotted on said graph in relation to said timeof day and calendar day. Optionally, at least one of a size, shape,color, or pattern of the icon is indicative of the patient's degree ofappetite.

Optionally, when executed, the third plurality of programmaticinstructions receives a weight trend of the patient and the appetitepattern and determines a composite score of the patient, wherein saidcomposite score is a function of the patient's historical degrees ofappetite and weight trend, and causes said composite score to bedisplayed on the client device. Optionally, when executed, the thirdplurality of programmatic instructions is configured to cause the clientdevice to transmit said composite score to an online affinity group,wherein the patient is a member of said online affinity group.

The present specification also discloses a system to generate real-timeinterventions in response to a patient's degree of appetite, comprising:an electrical dermal patch comprising: a housing; a controllerpositioned within the housing; at least one electrode in physicalcommunication with the housing and adapted to be in electrical contactwith the patient's skin; and, a pulse generator positioned within thehousing and in electrical communication with the controller and said atleast one electrode, wherein the pulse generator is configured togenerate a plurality of stimulation sessions comprising a plurality ofelectrical pulses defined by stimulation parameters; a first pluralityof programmatic instructions stored in a non-transient memory in aclient device separate from the electrical dermal patch, wherein, whenexecuted, said first plurality of programmatic instructions communicateswith said electrical dermal patch and prompts the patient to input dataindicative of the patient's degree of appetite via a microphone ordisplay of said client device; and a second plurality of programmaticinstructions stored in a non-transient memory in the client device oranother device separate from the electrical dermal patch, wherein, whenexecuted, the second plurality of programmatic instructions receives thedata indicative of the patient's degree of appetite, processes the dataindicative of the patient's degree of appetite to develop predictions ofwhether the patient's degree of appetite will be above or below athreshold value in a future time window, does not generate anyintervention in the future time window if the patient's degree ofappetite is expected to be below the threshold value, and causes a firstintervention to be generated in the future time window if the patient'sdegree of appetite is expected to be above the threshold value.

Optionally, the first intervention is a signal that is generated by thesecond plurality of programmatic instructions and is transmitted to theelectrical dermal patch in or before the future time window.

Optionally, the first intervention comprises at least one of graphics,text, audio, and video and said at least one of graphics, text, audio,and video comprises a pre-recorded message from an individual who isconnected with the patient within a social network.

Optionally, the first intervention comprises at least one of graphics,text, audio, and video and said at least one of graphics, text, audio,and video comprises a real-time message from an individual who isconnected with the patient within a social network.

The present specification also discloses an electrical dermal patchadapted to be continuously worn by a patient for at least 3 days,comprising: a housing comprising a controller in electricalcommunication with a pulse generator; and at least two electrodesadapted to be adhered to the patient's skin and in electricalcommunication with the pulse generator, wherein the controller comprisesprogrammatic instructions that, when executed and transmitted to thepulse generator, cause the pulse generator to generate and transmit tothe at least two electrodes a first set of electrical stimulation pulsesand a second set of electrical stimulation pulses and wherein each ofthe at least two electrodes comprise a hypoallergenic conductive gelwith at least one adhesive surface.

Optionally, the electrode does not comprise imidazolidinyl urea ordiazolidinyl urea.

Optionally, the electrode comprises carboxymethylcellulose polymer andpropylene glycol.

Optionally, the at least one adhesive surface is adapted to adhere tothe patient's skin and have a peel strength in a range of 1.0 to 2.1newtons.

Optionally, the at least one adhesive surface is adapted to adhere tothe patient's skin and have a total skin contact surface area in a rangeof 2 cm² to 4 cm².

Optionally, the at least two electrodes are positioned in a same planeparallel to the patient's skin and separated by a distance of 0.05 cm²to 0.4 cm².

Optionally, each of the electrical stimulation pulses is defined by acharged balanced biphasic waveform and the first set of electricalstimulation pulses and second set of electrical stimulation pulses areseparated by a predefined time interval. The predefined time intervalmay be in a range of 1 minute to 10 minutes.

Optionally, each of the electrical stimulation pulses is defined by awaveform characterized by a first period and a second period, whereinthe first period comprises a first 10 μs of the waveform and the secondperiod comprises a remainder of the waveform and said waveform isdefined by a maximum amplitude during the first period and an amplitudeless than said maximum amplitude during the second period. The maximumamplitude may be in a range of 20 to 50 mA. The maximum amplitude may bein a range of 20 to 50 mA and an average amplitude across said firstperiod and second period may be in a range of 10 mA to 30 mA.

Optionally, the pulse generator has a maximum compliance voltage in arange of 40 volts to 60 volts. Optionally, each of the electricalstimulation pulses is defined by a waveform characterized by a firstperiod, a second period, and a third period, wherein the first periodcomprises at least a portion of 0 to 10 μs of the waveform, the secondperiod comprises at least a portion of 10 μs to 100 μs of the waveform,and the third period comprises at least a portion of 100 μs to 200 μs ofthe waveform, wherein the first period is defined by a maximum amplitudeand the second and third periods are defined by a remainder amplitudeless than said maximum amplitude. Optionally, the maximum amplitude isin a range of 20 mA to 50 mA. Optionally, in the second period, a decayof said remainder amplitude is defined by a first negative slope havinga first magnitude and, in the third period, a decay of said remainderamplitude is defined by a second negative slope having a secondmagnitude, wherein the first magnitude is less than the secondmagnitude. Optionally, an average of the maximum amplitude and theremainder amplitude is in a range of 10 mA to 30 mA.

The present specification also discloses an electrical dermal patchadapted to be continuously worn by a patient for at least 3 days,comprising: a housing comprising a controller in electricalcommunication with a pulse generator; and two electrodes adapted to beadhered to the patient's skin, positioned in a same plane parallel tothe patient's skin, separated by a distance of 0.05 cm² to 0.4 cm². andin electrical communication with the pulse generator, wherein thecontroller comprises programmatic instructions that, when executed andtransmitted to the pulse generator, cause the pulse generator togenerate and transmit to the at least two electrodes a first set ofelectrical stimulation pulses and a second set of electrical stimulationpulses and wherein each of the at least two electrodes comprise ahypoallergenic conductive gel with at least one adhesive surface,wherein the hypoallergenic conductive gel does not compriseimidazolidinyl urea or diazolidinyl urea and wherein the at least oneadhesive surface is adapted to adhere to the patient's skin and have atotal skin contact surface area in a range of 2 cm² to 4 cm².

Optionally, the electrode comprises carboxymethylcellulose polymer andpropylene glycol.

Optionally, each of the electrical stimulation pulses is defined by acharged balanced biphasic waveform and the first set of electricalstimulation pulses and second set of electrical stimulation pulses areseparated by a predefined time interval. The predefined time intervalmay be randomized and is at least 1 minute.

Optionally, the pulse generator has a maximum compliance voltage in arange of 40 volts to 60 volts. Optionally, each of the electricalstimulation pulses is defined by a waveform characterized by a firstperiod, a second period, and a third period, wherein the first periodcomprises at least a portion of 0 to 10 μs of the waveform, the secondperiod comprises at least a portion of 10 μs to 100 μs of the waveform,and the third period comprises at least a portion of 100 μs to 200 μs ofthe waveform, wherein the first period is defined by a maximum amplitudeand the second and third periods are defined by a remainder amplitudeless than said maximum amplitude. Optionally, the maximum amplitude isin a range of 20 mA to 50 mA. Optionally, in the second period, a decayof said remainder amplitude is defined by a first negative slope havinga first magnitude and, in the third period, a decay of said remainderamplitude is defined by a second negative slope having a secondmagnitude, wherein the first magnitude is less than the secondmagnitude. Optionally, an average of the maximum amplitude and theremainder amplitude is in a range of 10 mA to 30 mA.

The present specification also discloses a method of using theelectrical dermal patch described above, comprising: programming thecontroller such that each of the electrical stimulation pulses comprisesa pulse width in a range of 10 μsec to 10 msec, a pulse amplitude in arange of 100 μA to 100 mA, and a pulse frequency in a range of 1 Hz and100 Hz; and evaluating if the patient experiences a change in appetiteas a result of an application of said first set of electricalstimulation pulses or said second set of electrical stimulation pulsesto the patient's skin, wherein the patient does not experience erythema,scaling, pruritus, folliculitis, or intertrigo at a point where said twoelectrodes adhere to the patient's skin.

In some embodiments, the present specification discloses an electricalstimulation system, comprising: an electrical dermal patch comprising ahousing, a controller positioned within the housing, at least oneelectrode positioned within the housing and adapted to be in electricalcontact with the patient's skin, a pulse generator positioned within thehousing and in electrical communication with the controller and said atleast one electrode, wherein the pulse generator is configured togenerate a plurality of stimulation sessions comprising a plurality ofelectrical pulses defined by stimulation parameters; and a firstplurality of programmatic instructions stored in a non-transient memoryin a client device separate from the electrical dermal patch, wherein,when executed by said client device, said first plurality ofprogrammatic instructions communicates with said electrical dermalpatch, acquires glucose status data of said patient, generates amodulation signal based upon said glucose status data and causes saidmodulation signal to be transmitted to the electrical dermal patch.

Optionally, the stimulation parameters comprise a pulse width in a rangeof 10 μsec to 10 msec, a pulse amplitude in a range of 100 μA to 100 mA,and a pulse frequency in a range of 1 Hz and 100 Hz.

Optionally, the modulation signal defines a second plurality ofstimulation parameters, wherein said second plurality of stimulationparameters comprise a second pulse width in a range of 10 μsec to 10msec, a second pulse amplitude in a range of 100 μA to 100 mA, and asecond pulse frequency in a range of 1 Hz and 100 Hz and wherein atleast one of the pulse width is different from the second pulse width,the pulse amplitude is different from the second pulse amplitude, andthe pulse frequency is different from the second pulse frequency.

Optionally, the second plurality of stimulation parameters are selectedsuch that, after applying a stimulation session defined by the secondplurality of stimulation parameters, a glycemic indicator of the patientimproves relative to the patient's said glycemic indicator prior toapplying the stimulation session.

Optionally, the first plurality of programmatic instructions prompts thepatient to input glucose status data by causing a visual analog scale tobe displayed on said client device.

Optionally, when executed, the first plurality of programmaticinstructions generates the modulation signal based upon a time of day.

Optionally, when executed, the first plurality of programmaticinstructions acquires said glucose status data from a second devicecomprising a glucose sensor configured to periodically and automaticallyacquire said glucose status data and wirelessly communicate said glucosestatus data to said client device.

Optionally, the electrical dermal patch comprises a glucose sensor toperiodically and automatically monitor and record said glucose statusdata of the patient.

Optionally, when executed, the first plurality of programmaticinstructions prompts the patient to input data indicative of thepatient's degree of appetite via a microphone or display of said clientdevice.

Optionally, when executed, the first plurality of programmaticinstructions generates a modulation signal based upon said glucosestatus data and said data indicative of the patient's degree ofappetite.

In some embodiments, the present specification discloses an electricalstimulation system, comprising: an electrical dermal patch comprising ahousing, a controller positioned within the housing, at least oneelectrode positioned within the housing and adapted to be in electricalcontact with the patient's skin, a pulse generator positioned within thehousing and in electrical communication with the controller and said atleast one electrode, wherein the pulse generator is configured togenerate a plurality of stimulation sessions comprising a plurality ofelectrical pulses defined by stimulation parameters; and a firstplurality of programmatic instructions stored in a non-transient memoryin a client device separate from the electrical dermal patch, wherein,when executed by said client device, said first plurality ofprogrammatic instructions communicates with said electrical dermalpatch, prompts the patient to input data indicative of the patient'sdegree of appetite via a microphone or display of said client device,acquires glucose status data of said patient, generates a modulationsignal based upon said glucose status data and a time of day and causessaid modulation signal to be transmitted to the electrical dermal patch.

Optionally, when executed, the first plurality of programmaticinstructions prompts the patient to input said data indicative of thepatient's degree of appetite by causing a visual analog scale to bedisplayed on said client device.

Optionally, when executed, the first plurality of programmaticinstructions further generates the modulation signal based upon saiddata indicative of the patient's degree of appetite.

Optionally, the stimulation parameters comprise a session frequency, asession duration, a pulse width in a range of 10 μsec to 10 msec, apulse amplitude in a range of 100 μA to 100 mA, and a pulse frequency ina range of 1 Hz and 100 Hz and wherein said modulation signal defines asecond plurality of stimulation parameters, wherein said secondplurality of stimulation parameters comprise a second session frequency,a second session duration, second pulse width in a range of 10 μsec to10 msec, a second pulse amplitude in a range of 100 μA to 100 mA, and asecond pulse frequency in a range of 1 Hz and 100 Hz.

Optionally, when executed, the first plurality of programmaticinstructions receives said glucose status data before 11 am, examinessaid glucose status data to determine if a glucose level of the patientis greater than 100 mg/dl, and, based on said determination, generatessaid modulation signal configured to cause the electrical dermal patchto generate an electrical stimulation after 5 pm.

Optionally, when executed, the first plurality of programmaticinstructions receives said glucose status data before 11 am, examinessaid glucose status data to determine if a glucose level of the patientis greater than 100 mg/dl, and, based on said determination, generatessaid modulation signal configured to cause the electrical dermal patchto generate an electrical stimulation after 5 pm, wherein saidmodulation signal comprises at least one of an increased second sessionfrequency relative to the session frequency, an increased second sessionduration relative to the session duration, an increased second pulseamplitude relative to the pulse amplitude, and an increased second pulsefrequency relative to the pulse frequency.

Optionally, when executed, the first plurality of programmaticinstructions receives said glucose status data periodically throughout aday, examines said glucose status data to determine if a glucose levelof the patient is greater than 140 mg/dl, and, based on saiddetermination, generates said modulation signal configured to cause theelectrical dermal patch to generate an electrical stimulation within twohours after determining the glucose level is greater than 140 mg/dl.

Optionally, when executed, the first plurality of programmaticinstructions receives said glucose status data periodically throughout aday, examines said glucose status data to determine if a glucose levelof the patient is greater than 140 mg/dl, examines data indicative ofthe patient's degree of appetite, and, based on said determination,generates said modulation signal configured to generate an electricalstimulation within two hours after determining the glucose level isgreater than 140 mg/dl and the patient's degree of appetite is greaterthan a predefined number.

Optionally, when executed, the first plurality of programmaticinstructions receives said glucose status data, examines said glucosestatus data to determine if a glucose level of the patient is less than80 mg/dl, and, based on said determination, generates said modulationsignal.

Optionally, when executed, the first plurality of programmaticinstructions receives said glucose status data, examines said glucosestatus data to determine if a glucose level of the patient is less than80 mg/dl, and, based on said determination, generates said modulationsignal, wherein said modulation signal comprises at least one of adecreased second session frequency relative to the session frequency, adecreased second session duration relative to the session duration, adecreased second pulse amplitude relative to the pulse amplitude, and adecreased second pulse frequency relative to the pulse frequency.

Optionally, when executed, the first plurality of programmaticinstructions receives said glucose status data, examines said glucosestatus data to determine if a rate of increase in a glucose level of thepatient is more than 2 mg/dl per minute, and, based on saiddetermination, generates said modulation signal.

Optionally, when executed, the first plurality of programmaticinstructions receives said glucose status data, examines said glucosestatus data to determine if a rate of increase in a glucose level of thepatient is more than 2 mg/dl per minute, and, based on saiddetermination, generates said modulation signal, wherein said modulationsignal comprises at least one of an increased second session frequencyrelative to the session frequency, an increased second session durationrelative to the session duration, an increased second pulse amplituderelative to the pulse amplitude, and an increased second pulse frequencyrelative to the pulse frequency.

Optionally, the second plurality of stimulation parameters are selectedsuch that, after applying a stimulation session defined by the secondplurality of stimulation parameters, a glucose level of the patient isreduced by 20 mg/dl.

Optionally, the second plurality of stimulation parameters are selectedsuch that, after applying a stimulation session defined by the secondplurality of stimulation parameters, a level of hemoglobin A1C in thepatient decreases by at least 1% relative to the patient's level ofhemoglobin A1C prior to applying the stimulation session.

Optionally, the second plurality of stimulation parameters are selectedsuch that, after applying a stimulation session defined by the secondplurality of stimulation parameters, a hepatic gluconeogenesis of saidpatient is lowered by at least 1% relative to the hepaticgluconeogenesis prior to applying the stimulation session.

Optionally, the second plurality of stimulation parameters are selectedsuch that, after applying a stimulation session defined by the secondplurality of stimulation parameters, a degree of insulin resistance ofthe patient improves by at least 1% relative to the patient's degree ofinsulin resistance prior to applying the stimulation session.

Optionally, the second plurality of stimulation parameters are selectedsuch that, after applying a stimulation session defined by the secondplurality of stimulation parameters, a level of glucose homeostasis ofthe patient improves by at least 1% relative to the patient's glucosehomeostasis prior to applying said stimulation session.

Optionally, the second plurality of stimulation parameters are selectedsuch that, after applying a stimulation session defined by the secondplurality of stimulation parameters, a level of HOMA-IR of the patientdecreases by at least 4% compared to a level of HOMA-IR prior toapplying said stimulation session.

In some embodiments, the present specification discloses a system togenerate real-time interventions in response to a patient's degree ofappetite, comprising: an electrical dermal patch comprising a housing, acontroller positioned within the housing, at least one electrodepositioned within the housing and adapted to be in electrical contactwith the patient's skin, a pulse generator positioned within the housingand in electrical communication with the controller and said at leastone electrode, wherein the pulse generator is configured to generate aplurality of stimulation sessions comprising a plurality of electricalpulses defined by stimulation parameters, wherein said stimulationparameters comprise a pulse width in a range of 10 μsec to 10 msec, apulse amplitude in a range of 100 μA to 100 mA, and a pulse frequency ina range of 1 Hz and 100 Hz; a first plurality of programmaticinstructions stored in a non-transient memory in a client deviceseparate from the electrical dermal patch, wherein, when executed, saidfirst plurality of programmatic instructions communicates with saidelectrical dermal patch, prompts the patient to input data indicative ofthe patient's degree of appetite via a microphone or display of saidclient device, and transmits said data indicative of the patient'sdegree of appetite to at least one server; and a second plurality ofprogrammatic instructions stored in a non-transient memory in said atleast one server, wherein, when executed, said second plurality ofprogrammatic instructions receives the data indicative of the patient'sdegree of appetite, processes the data indicative of the patient'sdegree of appetite to determine if the patient's degree of appetitefalls between a first threshold value and a second threshold value orbetween the second threshold value and a third threshold value, whereineach of the first threshold value, second threshold value, and thirdthreshold value are different, causes a first intervention to betransmitted to the client device if the patient's degree of appetitefalls between the first threshold value and the second threshold valueand causes a second intervention to be transmitted to the client deviceif the patient's degree of appetite falls between the second thresholdvalue and the third threshold value, wherein the first intervention isdifferent from the second intervention and wherein each of the firstintervention and second intervention is transmitted from the at leastone server to the client device and presented to the patient via saidclient device.

Optionally, when executed, said first plurality of programmaticinstructions generates a visual prompt in a form of a visual analogscale and causes said visual prompt to be displayed on the clientdevice, wherein each value along said visual analog scale isrepresentative of a different degree of appetite.

Optionally, when executed, said first plurality of programmaticinstructions transmits to said electrical dermal patch a signal inresponse to said data indicative of the patient's degree of appetite.

Optionally, when executed, said first plurality of programmaticinstructions generates a visual prompt in a form of a plurality of iconsand causes said visual prompt to be displayed on the client device,wherein each of said plurality of icons is representative of a differentdegree of appetite.

Optionally, when executed, said first plurality of programmaticinstructions generates a plurality of auditory inquires and causes saidplurality of auditory inquiries to be played via a speaker of saidclient device.

Optionally, the first intervention comprises at least one of graphics,text, audio, and video and wherein said at least one of graphics, text,audio, and video comprises coaching instructions to assist the patientin achieving dietary compliance.

Optionally, the second intervention comprises at least one of graphics,text, audio, and video and wherein said at least one of graphics, text,audio, and video comprises messages from individuals who are connectedwith the patient within a social network.

Optionally, when executed, the second plurality of programmaticinstructions processes the data indicative of the patient's degree ofappetite to determine if the patient's degree of appetite falls betweenthe third threshold value and a fourth threshold value, wherein thefourth threshold value is different than the first threshold value, thesecond threshold value, and the third threshold value and causes a thirdintervention to be transmitted to the client device if the patient'sdegree of appetite falls between the third threshold value and thefourth threshold value; wherein the third intervention is different fromthe first and second interventions and wherein the third intervention istransmitted from the at least one server to the client device andpresented to the patient via said display.

Optionally, the first intervention comprises at least one of graphics,text, audio, and video and wherein said at least one of graphics, text,audio, and video comprises data indicative of the patient's appetiteprofile.

Optionally, the second intervention comprises at least one of graphics,text, audio, and video and wherein said at least one of graphics, text,audio, and video comprises a pre-recorded message from an individual whois connected with the patient within a social network.

Optionally, the third intervention comprises at least one of graphics,text, audio, and video and wherein said at least one of graphics, text,audio, and video comprises a real-time message from an individual who isconnected with the patient within a social network.

Optionally, when executed, at least one of the first plurality ofprogrammatic instructions and the second plurality of programmaticinstructions receives a weight trend of the patient and a plurality ofvalues indicative of the patient's historical degrees of appetite,determines a composite score of the patient, wherein said compositescore is a function of the patient's historical degrees of appetite andweight trend, and causes said composite score to be displayed on theclient device.

Optionally, when executed, at least one of the first plurality ofprogrammatic instructions and the second plurality of programmaticinstructions transmits said composite score to an online affinity group,wherein the patient is a member of said online affinity group.

Optionally, when executed, at least one of the first plurality ofprogrammatic instructions and the second plurality of programmaticinstructions receives a composite score of a member of an onlineaffinity group, wherein said composite score of the member is a functionof the member's historical appetite scores and weight trends and causessaid composite score of the member to be displayed on the client device.

Optionally, when executed, at least one of the first plurality ofprogrammatic instructions and the second plurality of programmaticinstructions receives a weight trend of the patient, a plurality ofvalues indicative of the patient's historical degrees of appetite, aplurality of values indicative of the patient's historical amount ofexercise and a plurality of values indicative of the patient'shistorical well-being, determines a composite score of the patient,wherein said composite score is a function of the patient's historicaldegrees of appetite, weight trend, historical well-being, and historicalamount of exercise, and causes said composite score to be displayed onthe client device.

In some embodiments, the present specification discloses a system togenerate real-time interventions in response to a patient's degree ofappetite, comprising: an electrical dermal patch comprising a housing, acontroller positioned within the housing, at least one electrodepositioned within the housing and adapted to be in electrical contactwith the patient's skin, a pulse generator positioned within the housingand in electrical communication with the controller and said at leastone electrode, wherein the pulse generator is configured to generate aplurality of stimulation sessions comprising a plurality of electricalpulses defined by stimulation parameters, wherein said stimulationparameters comprise a pulse width in a range of 10 μsec to 10 msec, apulse amplitude in a range of 100 μA to 100 mA, and a pulse frequency ina range of 1 Hz and 100 Hz; a first plurality of programmaticinstructions stored in a non-transient memory in a client deviceseparate from the electrical dermal patch, wherein, when executed, saidfirst plurality of programmatic instructions communicates with saidelectrical dermal patch, prompts the patient to input data indicative ofthe patient's degree of appetite via a microphone or display of saidclient device, and transmits said data indicative of the patient'sdegree of appetite to at least one server; and a second plurality ofprogrammatic instructions stored in a non-transient memory in said atleast one server, wherein, when executed, said second plurality ofprogrammatic instructions receives the data indicative of the patient'sdegree of appetite, processes the data indicative of the patient'sdegree of appetite to determine if the patient's degree of appetite isabove or below a threshold value, does not cause any intervention to betransmitted to the client device if the patient's degree of appetitefalls below the threshold value and causes a first intervention to betransmitted to the client device if the patient's degree of appetite isabove the threshold value.

Optionally, when executed, at least one of the first plurality ofprogrammatic instructions and second plurality of programmaticinstructions processes the data indicative of the patient's degree ofappetite to determine when, at a future time, said patient will behungry.

Optionally, when executed, the first plurality of programmaticinstructions transmits a signal to the electrical dermal patchpositioned on the patient's skin based upon said future time.

Optionally, when executed, said first plurality of programmaticinstructions generates a visual prompt in a form of a visual analogscale, wherein each value along said visual analog scale isrepresentative of a different degree of appetite.

Optionally, the visual prompt is a light bar having a sliding scale,wherein one end of the sliding scale is indicative of a low degree ofappetite and a second end of the sliding scale is indicative of a highdegree of appetite.

Optionally, when executed, said first plurality of programmaticinstructions transmits to said electrical dermal patch a signal inresponse to data indicative of said high degree of appetite.

Optionally, when executed, said first plurality of programmaticinstructions generate a visual prompt in a form of a plurality of iconsand wherein each of said plurality of icons is representative of adifferent degree of appetite.

Optionally, when executed, said first plurality of programmaticinstructions generates a plurality of auditory inquires, via a speakerof said client device, to prompt a user to verbally respond with saiddata indicative of the patient's degree of appetite.

Optionally, the first intervention comprises at least one of graphics,text, audio, and video and wherein said at least one of graphics, text,audio, and video comprises coaching instructions to assist the patientin achieving dietary compliance.

Optionally, the first intervention comprises at least one of graphics,text, audio, and video and wherein said at least one of graphics, text,audio, and video comprises a pre-recorded message from an individual whois connected with the patient within a social network.

Optionally, the first intervention comprises at least one of graphics,text, audio, and video and wherein said at least one of graphics, text,audio, and video comprises a real-time message from an individual who isconnected with the patient within a social network.

Optionally, when executed, at least one of the first plurality ofprogrammatic instructions and the second plurality of programmaticinstructions receives a weight trend of the patient and a plurality ofvalues indicative of the patient's historical degrees of appetite,determines a composite score of the patient, wherein said compositescore is a function of the patient's historical degrees of appetite andweight trend, and causes said composite score to be displayed on theclient device.

Optionally, when executed, at least one of the first plurality ofprogrammatic instructions and the second plurality of programmaticinstructions transmits said composite score to an online affinity group,wherein the patient is a member of said online affinity group.

Optionally, when executed, at least one of the first plurality ofprogrammatic instructions and the second plurality of programmaticinstructions receives a composite score of a member of an onlineaffinity group, wherein said composite score of the member is a functionof the member's historical appetite scores and weight trends and causessaid composite score of the member to be displayed on the client device.

Optionally, when executed, at least one of the first plurality ofprogrammatic instructions and the second plurality of programmaticinstructions receives a weight trend of the patient, a plurality ofvalues indicative of the patient's historical degrees of appetite, aplurality of values indicative of the patient's historical amount ofexercise and a plurality of values indicative of the patient'shistorical well-being, determines a composite score of the patient,wherein said composite score is a function of the patient's historicaldegrees of appetite, weight trend, historical well-being, and historicalamount of exercise, and causes said composite score to be displayed onthe client device.

In some embodiments, the present specification discloses a method ofenabling a patient to achieve a weight loss objective, comprising:providing the patient with an electrical dermal patch comprising ahousing, an electrical pulse generator positioned within the housing,and at least one electrode attached to said housing and in electricalcommunication with the electrical pulse generator, wherein saidelectrical pulse generator is configured to deliver electrical pulseshaving a pulse amplitude in a range of 5 mA to 45 mA; instructing thepatient to secure the electrical dermal patch to the patient's skin;applying a plurality of stimulation sessions to the patient's skin usingsaid electrical dermal patch over a duration of one week, wherein eachof the plurality of stimulation sessions comprises said electricalpulses, wherein at least some of the plurality of stimulation sessionshave a duration of at least 15 minutes, and wherein the plurality ofstimulation sessions comprises at least one in said week; andinstructing the patient to repeatedly apply said plurality ofstimulation sessions until said weight loss objective is achieved.

Optionally, each of said electrical pulses is defined by a plurality ofstimulation parameters and wherein said plurality of stimulationparameters comprises a pulse width in a range of 10 μsec to 10 msec anda pulse frequency in a range of 1 Hz and 100 Hz.

Optionally, a total energy delivered by the plurality of stimulationsessions applied over said one week is not less than 0.25 joules.

Optionally, the plurality of stimulation sessions comprises at least twoin said week and wherein each of said two stimulation sessions occurs ondifferent days of said week.

Optionally, a total energy delivered by one of said plurality ofstimulation sessions does not exceed 6 joules.

Optionally, the plurality of stimulation sessions comprises at leastseven in said week and wherein each of said seven stimulation sessionsoccurs on different days of said week.

Optionally, a first of said plurality of stimulation sessions isseparated from a second of said plurality of stimulation sessions by anamount of time equal to or greater than one quarter of a duration of thesecond of said plurality of stimulation sessions.

Optionally, the method further comprises instructing the patient torepeatedly apply said plurality of stimulation sessions over a minimumof four weeks.

Optionally, the method further comprises causing the patient to lose aminimum of two pounds over said minimum of four weeks.

Optionally, the method further comprises instructing the patient torepeatedly apply said plurality of stimulation sessions over a minimumof four weeks and causing the patient to lose an amount of weight oversaid minimum of four weeks such that the patient maintains a loss of atleast 90% of said amount of weight lost for at least 30 days afterapplying a last of said plurality of stimulation sessions.

Optionally, the method further comprises applying at least three of saidplurality of stimulation sessions to the patient's skin each day usingsaid electrical dermal patch, wherein each of the three of saidplurality of stimulation sessions occurs on different days of said week,wherein said plurality of stimulation parameters, including said pulsewidth, said pulse frequency, and said pulse amplitude, are set such thatan antral activity of the patient is slowed from a first level to asecond level after applying at least one of said three of said pluralityof stimulation sessions and wherein said second level of antral activityis maintained for at least 1 hour after applying a last of saidplurality of stimulation sessions.

Optionally, the method further comprises generating, via the electricaldermal patch, at least one of a visual, auditory, and vibratory signalto the patient within 30 minutes before initiating one of said pluralityof stimulation sessions.

Optionally, the method further comprises instructing the patient tomanually trigger at least one of the plurality of stimulation sessionsby generating at least one of a visual, auditory and vibratory signalusing the electrical dermal patch within 30 minutes before initiatingone of said plurality of stimulation sessions.

Optionally, the method further comprises instructing the patient tosecure the electrical dermal patch to the patient's skin by generatingat least one of a visual, auditory, and vibratory signal using theelectrical dermal patch within 60 minutes before initiating one of saidplurality of stimulation sessions.

Optionally, the method further comprises instructing the patient tosecure the electrical dermal patch to the patient's skin by generatingat least one of a visual, auditory, and vibratory signal using theelectrical dermal patch within 60 minutes after initiating a wake upalarm.

In some embodiments, the present specification discloses a method ofenabling a patient to achieve a weight loss objective, comprising:providing the patient with an electrical dermal patch comprising ahousing, an electrical pulse generator positioned within the housing,and at least one electrode attached to said housing and in electricalcommunication with the electrical pulse generator, wherein saidelectrical pulse generator is configured to deliver electrical pulseshaving a pulse amplitude in a range of 5 mA to 45 mA, a pulse width in arange of 10 μsec to 10 msec, and a pulse frequency in a range of 1 Hzand 100 Hz; instructing the patient to secure the electrical dermalpatch to the patient's skin; applying a plurality of stimulationsessions to the patient's skin using said electrical dermal patch over aduration of one week, wherein each of the plurality of stimulationsessions comprises said electrical pulses and has a duration of at least15 minutes and wherein the plurality of stimulation sessions comprisesat least two in said week occurring on different days of the week; andinstructing the patient to repeatedly apply said plurality ofstimulation sessions for a minimum of four weeks.

Optionally, said electrical dermal patch is programmed to apply at leasta portion of said plurality of stimulation sessions between 6 am and 9am, between 11 am and 2 pm or between 5 pm and 9 pm.

Optionally, a total energy delivered by the plurality of stimulationsessions applied over said one week is not less than 0.5 joules.

Optionally, a total energy delivered by one of said plurality ofstimulation sessions does not exceed 6 joules.

Optionally, each of said plurality of stimulation sessions is separatedfrom a subsequent one of said plurality of stimulation sessions by anamount of time equal to or greater than 25% of a duration of thesubsequent one of said plurality of stimulation sessions.

Optionally, the method further comprises causing the patient to lose aminimum of two pounds over said minimum of four weeks.

Optionally, the method further comprises instructing the patient torepeatedly apply said plurality of stimulation sessions over a minimumof four weeks and causing the patient to lose an amount of weight oversaid minimum of four weeks such that the patient maintains a loss of atleast 90% of said amount of weight lost for at least 30 days afterapplying a last of said plurality of stimulation sessions.

Optionally, the method further comprises applying at least two of saidplurality of stimulation sessions to the patient's skin each day usingsaid electrical dermal patch.

Optionally, the method further comprises generating, via the electricaldermal patch, at least one of a visual, auditory and vibratory signal tothe patient within 30 minutes before initiating one of said plurality ofstimulation sessions.

Optionally, the method further comprises instructing the patient tomanually trigger at least one of the plurality of stimulation sessionsby generating at least one of a visual, auditory and vibratory signalusing the electrical dermal patch within 30 minutes before initiatingone of said plurality of stimulation sessions.

Optionally, the method further comprises instructing the patient tosecure the electrical dermal patch to the patient's skin by generatingat least one of a visual, auditory and vibratory signal using theelectrical dermal patch within 60 minutes before initiating one of saidplurality of stimulation sessions.

In some embodiments, the present specification discloses a method ofenabling a patient to achieve a weight loss objective, comprising:providing the patient with an electrical dermal patch comprising ahousing, an electrical pulse generator positioned within the housing,and at least one electrode attached to said housing and in electricalcommunication with the electrical pulse generator, wherein saidelectrical pulse generator is configured to deliver electrical pulseshaving a pulse amplitude in a range of 5 mA to 45 mA, a pulse width in arange of 10 μsec to 10 msec, and a pulse frequency in a range of 1 Hzand 100 Hz; instructing the patient to secure the electrical dermalpatch to the patient's skin on at least one of the patient's C5, C6, C7,C8, T1, T2, T3, T4, T5, T6, T7, T8, T9, T10, T11, and T12 frontal andlateral dermatomes; applying a plurality of stimulation sessions to thepatient's skin using said electrical dermal patch over a duration of oneweek, wherein each of the plurality of stimulation sessions comprisessaid electrical pulses, wherein at least some of the plurality ofstimulation sessions have a duration of at least 15 minutes, wherein theplurality of stimulation sessions comprises at least one in said week,and wherein a total energy delivered by any one of the plurality ofstimulation sessions does not exceed 6 joules and a total energydelivered by all of the plurality of stimulation sessions applied oversaid one week is not less than 0.5 joules; and instructing the patientto repeatedly apply said plurality of stimulation sessions for a minimumof four weeks.

Optionally, said electrical dermal patch is programmed to apply at leasta portion of said plurality of stimulation sessions between 6 am and 9am, between 11 am and 2 pm or between 5 pm and 9 pm.

Optionally, the method further comprises applying at least two of saidplurality of stimulation sessions to the patient's skin on differentdays of said week using said electrical dermal patch and wherein each ofsaid at least two of said plurality of stimulation sessions has aduration of at least 15 minutes.

Optionally, the method further comprises generating, via the electricaldermal patch, at least one of a visual, auditory, and vibratory signalto the patient within 30 minutes before initiating one of said pluralityof stimulation sessions.

Optionally, the method further comprises instructing the patient tomanually trigger at least one of the plurality of stimulation sessionsby generating at least one of a visual, auditory, and vibratory signalto the patient within 30 minutes before initiating one of said pluralityof stimulation sessions.

Optionally, the method further comprises instructing the patient tosecure the electrical dermal patch to the patient's skin by generatingat least one of a visual, auditory, and vibratory signal to the patientwithin 60 minutes before initiating one of said plurality of stimulationsessions.

Optionally, none of said plurality of stimulation sessions applied tothe patient's skin over said week has a duration for more than 12 hoursand has said pulse amplitude greater than 45 mAmps.

In some embodiments, the present specification discloses an electricaldermal patch configured to cause a delay in emptying of a patient'sstomach contents, comprising: a housing having a base surface, whereinsaid base surface is defined by a total base surface area epidermis; acontroller positioned within the housing; at least one electrode havinga base surface and attached to the base surface of said housing, whereinthe base surface of the at least one electrode is adapted to be inelectrical contact with said patient's epidermis and wherein at leastone of the base surface of the at least one electrode and the basesurface of the housing is adapted to be adhered to an epidermis of thepatient; and a pulse generator positioned within the housing and inelectrical communication with the controller and said at least oneelectrode, wherein the pulse generator is configured to generate aplurality of stimulation sessions, wherein each of said plurality ofstimulation sessions comprises a plurality of electrical pulses andwherein each of said plurality of electrical pulses is defined by aplurality of stimulation parameters, said plurality of stimulationparameters being defined such that, after applying at least one of saidplurality of stimulation sessions to the epidermis of the patient within90 minutes of said patient consuming a meal, a post-prandial time toempty 50% of the patient's stomach contents increases by at least 5%relative to a post-prandial time to empty 50% of the patient's stomachcontents without applying at least one of said plurality of stimulationsessions.

Optionally, said electrical dermal patch is adapted to be adhered to theepidermis of the patient such that an electrical field, generated bysaid plurality of stimulation sessions, directly contacts at least oneof the patient's C5, C6, C7, C8, T1, T2, T3, T4, T5, T6, T7, T8, T9,T10, T11, and T12 frontal and lateral dermatomes, does not directlycontact the patient's gastrointestinal tract, does not directly contactthe patient's vagus nerve, and penetrates a range of 0.1 mm to 25 mmthrough the patient's epidermis.

Optionally, the base surface of the housing is not configured to beadhered to the patient's epidermis and is positioned less than 4 mmabove the patient's epidermis and wherein the base surface of the atleast one electrode is configured to be adhered to the patient'sepidermis and has a maximum surface area contacting said epidermis of 10in².

Optionally, the electrical dermal patch further comprises a secondelectrode and wherein the at least one electrode and second electrodeare separated by a distance of less than 20 mm and wherein the housing,the at least one electrode, and the second electrode, in combination,have a height not exceeding 1 inch.

Optionally, said plurality of stimulation parameters are further definedsuch that each of said plurality of electrical pulses has a pulse widthof less than 1 ms and wherein the at least one electrode is a foamelectrode or a hydrocolloid electrode.

Optionally, said plurality of stimulation parameters are further definedsuch that, after applying at least one of said plurality of stimulationsessions to the epidermis of the patient within 90 minutes of saidpatient consuming the meal, the post-prandial time to empty 95% of thepatient's stomach contents increases by at least 5% relative to thepost-prandial time to empty 95% of the patient's stomach contentswithout applying at least one of said plurality of stimulation sessions.

Optionally, the electrical dermal patch further comprises a transceiverin communication with at least one of said controller and pulsegenerator and a plurality of programmatic instructions, stored in anon-transient computer readable memory of a device physically separatefrom said electrical dermal patch, wherein, when executed, saidprogrammatic instructions acquire patient status data, generate amodulation signal based upon said patient status data, and wirelesslytransmit said modulation signal from the device to the transceiver,wherein said modulation signal comprises data for modulating at leastone of said plurality of stimulation parameters.

Optionally, said patient status data comprises at least one of thepatient's hunger, the patient's hunger appetite, the patient's satietylevel, the patient's satiation level, and a degree of well-being beingexperienced by the patient.

Optionally, said plurality of stimulation parameters are further definedsuch that, after applying at least one of said plurality of stimulationsessions to the epidermis of the patient, the patient's appetite orhunger decreases relative to the patient's appetite or hunger beforeapplying said at least one of said plurality of stimulation sessions.

Optionally, said plurality of stimulation parameters are further definedsuch that, after applying at least one of said plurality of stimulationsessions to the epidermis of the patient, the patient's gastricretention increases by 5% relative to the patient's gastric retentionbefore applying said at least one of said plurality of stimulationsessions.

Optionally, said plurality of stimulation parameters are further definedsuch that, after applying at least one of said plurality of stimulationsessions to the epidermis of the patient, the patient's postprandialplasma glucose concentration decreases by at least 5% relative to thepatient's postprandial plasma glucose concentration without applyingsaid at least one of said plurality of stimulation sessions.

In some embodiments, the present specification discloses an electricaldermal patch configured to cause a delay in gastric emptying of apatient having a body mass index of at least 25 comprising: a housinghaving a base surface, wherein said base surface is defined by a totalbase surface area; a controller positioned within the housing; at leastone electrode having a base surface and attached to the base surface ofsaid housing, wherein the base surface of the at least one electrode isadapted to be in electrical contact with said patient's epidermis andwherein at least one of the base surface of the at least one electrodeand the base surface of the housing is adapted to be adhered to anepidermis of the patient; and a pulse generator positioned within thehousing and in electrical communication with the controller and said atleast one electrode, wherein the pulse generator is configured togenerate a plurality of stimulation sessions, wherein each of saidplurality of stimulation sessions comprises a plurality of electricalpulses and wherein each of said plurality of electrical pulses isdefined by a plurality of stimulation parameters, said plurality ofstimulation parameters being defined such that, after applying at leastone of said plurality of stimulation sessions for at least 5 minutes tothe epidermis of the patient within 90 minutes of said patient consuminga meal, a post-prandial time to empty 50% of the patient's stomachcontents increases by at least 5 minutes relative to a post-prandialtime to empty 50% of the patient's stomach contents without applying atleast one of said plurality of stimulation sessions.

Optionally, said electrical dermal patch is adapted to be adhered to theepidermis of the patient such that an electrical field, generated bysaid plurality of stimulation sessions, directly contacts at least oneof the patient's C5, C6, C7, C8, T1, T2, T3, T4, T5, T6, T7, T8, T9,T10, T11, and T12 frontal and lateral dermatomes, does not directlycontact the patient's gastrointestinal tract, does not directly contactthe patient's vagus nerve, and penetrates no more than 25 mm through thepatient's epidermis.

Optionally, the base surface of the housing is not configured to beadhered to the patient's epidermis and is positioned less than 4 mmabove the patient's epidermis and wherein the base surface of the atleast one electrode is configured to be adhered to the patient'sepidermis and has a maximum surface area contacting said epidermis of 10in².

Optionally, the electrical dermal patch further comprises a secondelectrode and wherein the at least one electrode and second electrodeare separated by a distance of less than 10 mm and wherein the housing,the at least one electrode, and the second electrode, in combination,have a height not exceeding 1 inch.

Optionally, the electrical dermal patch has a volume in a range from0.10 in³ to 0.5 in³, a weight in a range from 10 grams to 80 grams, anda ratio of a surface area of the base surface of the at least oneelectrode to said weight in a range of 0.1 to 0.8 in² per gram weight ofthe electrical dermal patch.

Optionally, said plurality of stimulation parameters are further definedsuch that, after applying at least one of said plurality of stimulationsessions for at least 5 minutes to the epidermis of the patient within90 minutes of said patient consuming the meal, the post-prandial time toempty 95% of the patient's stomach contents increases by at least 5minutes relative to the post-prandial time to empty 95% of the patient'sstomach contents without applying at least one of said plurality ofstimulation sessions.

Optionally, the electrical dermal patch further comprises a transceiverin communication with at least one of said controller and pulsegenerator and a plurality of programmatic instructions, stored in anon-transient computer readable memory of a device physically separatefrom said electrical dermal patch, wherein, when executed, saidprogrammatic instructions acquire patient status data, generate amodulation signal based upon said patient status data, and wirelesslytransmit said modulation signal from the device to the transceiver,wherein said modulation signal comprises data for modulating at leastone of said plurality of stimulation parameters.

Optionally, said patient status data comprises at least one of thepatient's hunger, the patient's hunger appetite, the patient's satietylevel, the patient's satiation level, and a degree of well-being beingexperienced by the patient.

Optionally, said plurality of stimulation parameters are further definedsuch that, after applying at least one of said plurality of stimulationsessions to the epidermis of the patient, the patient's appetite orhunger decreases relative to the patient's appetite or hunger beforeapplying said at least one of said plurality of stimulation sessions anda nausea level of the patient does not increase relative to thepatient's nausea level before applying said at least one of saidplurality of stimulation sessions.

Optionally, said plurality of stimulation parameters are further definedsuch that, after applying at least one of said plurality of stimulationsessions to the epidermis of the patient, the patient's gastricretention increases by 5% relative to the patient's gastric retentionbefore applying said at least one of said plurality of stimulationsessions.

Optionally, the electrical dermal patch further comprises an adhesivelayer positioned a base surface of the at least one electrode andwherein, when the adhesive layer of the electrical dermal patch isconfigured to be adhered to the patient's epidermis, the electricaldermal patch has a peel strength in a range of 1.0 to 2.1 newtons.

Optionally, said plurality of stimulation parameters are further definedsuch that, after applying at least one of said plurality of stimulationsessions to the epidermis of the patient, a body weight of the patientreduces by at least 1% relative to a body weight of the patient beforeapplying said at least one of said plurality of stimulation sessions.

Optionally, when executed, said programmatic instructions acquire afirst stimulation protocol and use said first stimulation protocol togenerate the modulation signal. Still optionally, when executed, saidprogrammatic instructions acquire a second stimulation protocol, whereinsaid second stimulation protocol is different from the first stimulationprotocol, and, using said second stimulation protocol, generate a secondmodulation signal, wherein said second modulation signal comprises datafor modulating at least one of the plurality of stimulation parameters.

Optionally, the plurality of stimulation parameters comprise a firstpulse width, a first pulse amplitude, a first pulse frequency, a firstpulse shape, a first duty cycle, a first session duration, and a firstsession frequency, wherein the electrical dermal patch is configured touse the second modulation signal to modify at least one of the firstpulse width, the first pulse amplitude, the first pulse frequency, thefirst pulse shape, the first duty cycle, the first session duration, andthe first session frequency to yield a second pulse width, a secondpulse amplitude, a second pulse frequency, a second pulse shape, asecond duty cycle, a second session duration, or a second sessionfrequency, and wherein at least one of the second pulse width isdifferent from the first pulse width, the second pulse amplitude isdifferent from the first pulse amplitude, the second pulse frequency isdifferent from the first pulse frequency, the second pulse shape isdifferent from the first pulse shape, the second duty cycle is differentfrom the first duty cycle, the second session duration is different fromthe first session duration, and the second session frequency isdifferent from the first session frequency.

In some embodiments, the present specification discloses an electricaldermal patch configured to cause a delay in gastric emptying of apatient comprising: a housing; a controller positioned within thehousing; at least one electrode attached to said housing and adapted tobe in electrical contact with said patient's epidermis, wherein the atleast one electrode has a base surface defined by a total base surfacearea, wherein at least a portion of said total base surface area isadapted to be adhered to an epidermis of the patient, wherein saidportion of the total base surface area adapted to be adhered to theepidermis of the patient is no greater than 10 in², and wherein saidportion of the total base surface area is adapted to be adhered to theepidermis of the patient such that an electrical field, generated by aplurality of stimulation sessions, directly contacts at least one of thepatient's C5, C6, C7, C8, T1, T2, T3, T4, T5, T6, T7, T8, T9, T10, T11,and T12 frontal and lateral dermatomes; and a pulse generator positionedwithin the housing and in electrical communication with the controllerand said at least one electrode, wherein the pulse generator isconfigured to generate said plurality of stimulation sessions, whereineach of said plurality of stimulation sessions comprises a plurality ofelectrical pulses and wherein each of said plurality of electricalpulses is defined by a plurality of stimulation parameters, saidplurality of stimulation parameters being defined such that, afterapplying at least one of said plurality of stimulation sessions for atleast 5 minutes to the epidermis of the patient within 90 minutes ofsaid patient consuming a meal, a post-prandial time to empty 50% of thepatient's stomach contents increases by at least 5% relative to apost-prandial time to empty 50% of the patient's stomach contentswithout applying at least one of said plurality of stimulation sessions.

Optionally, the electrical dermal patch further comprises a transceiverin communication with at least one of said controller and pulsegenerator and a plurality of programmatic instructions, stored in anon-transient computer readable memory of a device physically separatefrom said electrical dermal patch, wherein, when executed, saidprogrammatic instructions acquire patient status data, generate amodulation signal based upon said patient status data, and wirelesslytransmit said modulation signal from the device to the transceiver,wherein said modulation signal comprises data for modulating at leastone of said plurality of stimulation parameters.

Optionally, said patient status data comprises at least one of thepatient's hunger, the patient's hunger appetite, the patient's satietylevel, the patient's satiation level, and a degree of well-being beingexperienced by the patient.

Optionally, said plurality of stimulation parameters are further definedsuch that, after applying at least one of said plurality of stimulationsessions to the epidermis of the patient, the patient's gastricretention increases by 5% relative to the patient's gastric retentionbefore applying said at least one of said plurality of stimulationsessions.

In some embodiments, the present specification discloses a method ofmodulating at least one of a patient's appetite, hunger, satiety level,or satiation level comprising: providing an electrical dermal patchadapted to adhere to the patient's epidermal layer, wherein saidelectrical dermal patch comprises a controller, at least one electrodeadapted to be in electrical contact with said patient's epidermal layer,and a pulse generator in electrical communication with the controllerand said at least one electrode; defining a plurality of stimulationparameters; and programming the pulse generator to generate a pluralityof electrical pulses using said plurality of stimulation parameters,wherein said plurality of stimulation parameters are defined such that,after applying at least one stimulation to the patient's epidermallayer, at least one of the patient's appetite, hunger, satiety level,and satiation level is modified.

Optionally, after applying at least one stimulation to the patient'sepidermal layer, the appetite of said patient decreases relative to theappetite of said patient prior to applying at least one stimulation.

Optionally, after applying at least one stimulation to the patient'sepidermal layer, the hunger of said patient decreases relative to thehunger of said patient prior to applying at least one stimulation.

Optionally, after applying at least one stimulation to the patient'sepidermal layer, the satiety level of said patient increases relative tothe satiety level of said patient prior to applying at least onestimulation.

Optionally, after applying at least one stimulation to the patient'sepidermal layer, the satiation level of said patient increases relativeto the satiation level of said patient prior to applying at least onestimulation.

Optionally, after applying at least one stimulation to the patient'sepidermal layer, the fullness level of said patient increases relativeto the fullness level of said patient prior to applying at least onestimulation.

Optionally, said plurality of stimulation parameters are defined suchthat, after applying at least one stimulation to the patient's epidermallayer, the patient's appetite modulates from a first state to a secondstate, wherein the first state is defined by a pre-stimulation appetiteprofile comprising a first plurality of quantitative appetitemeasurements, wherein each of said first plurality of quantitativeappetite measurements is determined, prior to stimulation, using avisual analog scale and is taken at different predefined times of day,wherein the second state is defined by a post-stimulation appetiteprofile comprising a second plurality of quantitative appetitemeasurements, wherein each of said second plurality of quantitativeappetite measurements is determined, after stimulation, using saidvisual analog scale and is taken at different predefined times of day,and wherein, for a given predefined time of day, at least one of thesecond plurality of quantitative appetite measurements differs from atleast one of the first plurality of quantitative appetite measurementsby at least 5%, thereby representing a decrease in appetite of thepatient.

Optionally, said plurality of stimulation parameters are defined suchthat, after applying at least one stimulation to the patient's epidermallayer, the patient's hunger modulates from a first state to a secondstate, wherein the first state is defined by a pre-stimulation hungerprofile comprising a first plurality of quantitative hungermeasurements, wherein each of said first plurality of quantitativehunger measurements is determined, prior to stimulation, using a visualanalog scale and is taken at different predefined times of day, whereinthe second state is defined by a post-stimulation hunger profilecomprising a second plurality of quantitative hunger measurements,wherein each of said second plurality of quantitative hungermeasurements is determined, after stimulation, using said visual analogscale and is taken at different predefined times of day, and wherein,for a given predefined time of day, at least one of the second pluralityof quantitative hunger measurements differs from at least one of thefirst plurality of quantitative hunger measurements by at least 5%,thereby representing a decrease in hunger of the patient.

Optionally, said plurality of stimulation parameters are defined suchthat, after applying at least one stimulation to the patient's epidermallayer, the patient's satiety level modulates from a first state to asecond state, wherein the first state is defined by a pre-stimulationsatiety profile comprising a first plurality of quantitative satietymeasurements, wherein each of said first plurality of quantitativesatiety measurements is determined, prior to stimulation, using a visualanalog scale and is taken at different predefined times of day, whereinthe second state is defined by a post-stimulation satiety profilecomprising a second plurality of quantitative satiety measurements,wherein each of said second plurality of quantitative satietymeasurements is determined, after stimulation, using said visual analogscale and is taken at different predefined times of day, and wherein,for a given predefined time of day, at least one of the second pluralityof quantitative satiety measurements differs from at least one of thefirst plurality of quantitative satiety measurements by at least 5%,thereby representing an increase in the satiety level of the patient.

Optionally, said plurality of stimulation parameters are defined suchthat, after applying at least one stimulation to the patient's epidermallayer, the patient's satiation level modulates from a first state to asecond state, wherein the first state is defined by a pre-stimulationsatiation profile comprising a first plurality of quantitative satiationmeasurements, wherein each of said first plurality of quantitativesatiation measurements is determined, prior to stimulation, using avisual analog scale and is taken at different predefined times of day,wherein the second state is defined by a post-stimulation satiationprofile comprising a second plurality of quantitative satiationmeasurements, wherein each of said second plurality of quantitativesatiation measurements is determined, after stimulation, using saidvisual analog scale and is taken at different predefined times of day,and wherein, for a given predefined time of day, at least one of thesecond plurality of quantitative satiation measurements differs from atleast one of the first plurality of quantitative satiation measurementsby at least 5%, thereby representing an increase in the satiation levelof the patient.

Optionally, said plurality of stimulation parameters are defined suchthat, after applying at least one stimulation to the patient's epidermallayer, the patient's fullness level modulates from a first state to asecond state, wherein the first state is defined by a pre-stimulationfullness profile comprising a first plurality of quantitative fullnessmeasurements, wherein each of said first plurality of quantitativefullness measurements is determined, prior to stimulation, using avisual analog scale and is taken at different predefined times of day,wherein the second state is defined by a post-stimulation fullnessprofile comprising a second plurality of quantitative fullnessmeasurements, wherein each of said second plurality of quantitativefullness measurements is determined, after stimulation, using saidvisual analog scale and is taken at different predefined times of day,and wherein, for a given predefined time of day, at least one of thesecond plurality of quantitative fullness measurements differs from atleast one of the first plurality of quantitative fullness measurementsby at least 5%, thereby representing an increase in the fullness levelof the patient.

Optionally, said plurality of stimulation parameters are defined suchthat, after applying at least one stimulation to the patient's epidermallayer, the patient's appetite modulates from a first state to a secondstate, wherein the first state is defined by a pre-stimulation appetiteprofile comprising a first plurality of quantitative appetitemeasurements, wherein each of said first plurality of quantitativeappetite measurements is determined, prior to stimulation, using avisual analog scale and is taken at different predefined times of day,wherein said first plurality of quantitative appetite measurementscollectively define a first area representative of said first state,wherein the second state is defined by a post-stimulation appetiteprofile comprising a second plurality of quantitative appetitemeasurements, wherein each of said second plurality of quantitativeappetite measurements is determined, after stimulation, using saidvisual analog scale and is taken at different predefined times of day,wherein said second plurality of quantitative appetite measurementscollectively define a second area representative of said second state,and wherein said first area differs from said second area by at least5%, thereby representing a decrease in the appetite of the patient.

Optionally, said plurality of stimulation parameters are defined suchthat, after applying at least one stimulation to the patient's epidermallayer, the patient's hunger modulates from a first state to a secondstate, wherein the first state is defined by a pre-stimulation hungerprofile comprising a first plurality of quantitative hungermeasurements, wherein each of said first plurality of quantitativehunger measurements is determined, prior to stimulation, using a visualanalog scale and is taken at different predefined times of day, whereinsaid first plurality of quantitative hunger measurements collectivelydefine a first area representative of said first state, wherein thesecond state is defined by a post-stimulation hunger profile comprisinga second plurality of quantitative hunger measurements, wherein each ofsaid second plurality of quantitative hunger measurements is determined,after stimulation, using said visual analog scale and is taken atdifferent predefined times of day, wherein said second plurality ofquantitative hunger measurements collectively define a second arearepresentative of said second state, and wherein said first area differsfrom said second area by at least 5%, thereby representing a decrease inthe hunger of the patient.

Optionally, said plurality of stimulation parameters are defined suchthat, after applying at least one stimulation to the patient's epidermallayer, the patient's satiety level modulates from a first state to asecond state, wherein the first state is defined by a pre-stimulationsatiety profile comprising a first plurality of quantitative satietymeasurements, wherein each of said first plurality of quantitativesatiety measurements is determined, prior to stimulation, using a visualanalog scale and is taken at different predefined times of day, whereinsaid first plurality of quantitative satiety measurements collectivelydefine a first area representative of said first state, wherein thesecond state is defined by a post-stimulation satiety profile comprisinga second plurality of quantitative satiety measurements, wherein each ofsaid second plurality of quantitative satiety measurements isdetermined, after stimulation, using said visual analog scale and istaken at different predefined times of day, wherein said secondplurality of quantitative satiety measurements collectively define asecond area representative of said second state, and wherein said firstarea differs from said second area by at least 5%, thereby representingan increase in the satiety level of the patient.

Optionally, said plurality of stimulation parameters are defined suchthat, after applying at least one stimulation to the patient's epidermallayer, the patient's satiation level modulates from a first state to asecond state, wherein the first state is defined by a pre-stimulationsatiation profile comprising a first plurality of quantitative satiationmeasurements, wherein each of said first plurality of quantitativesatiation measurements is determined, prior to stimulation, using avisual analog scale and is taken at different predefined times of day,wherein said first plurality of quantitative satiation measurementscollectively define a first area representative of said first state,wherein the second state is defined by a post-stimulation satiationprofile comprising a second plurality of quantitative satiationmeasurements, wherein each of said second plurality of quantitativesatiation measurements is determined, after stimulation, using saidvisual analog scale and is taken at different predefined times of day,wherein said second plurality of quantitative satiation measurementscollectively define a second area representative of said second state,and wherein said first area differs from said second area by at least5%, thereby representing an increase in the satiation level of thepatient.

Optionally, said plurality of stimulation parameters are defined suchthat, after applying at least one stimulation to the patient's epidermallayer, the patient's fullness level modulates from a first state to asecond state, wherein the first state is defined by a pre-stimulationfullness profile comprising a first plurality of quantitative fullnessmeasurements, wherein each of said first plurality of quantitativefullness measurements is determined, prior to stimulation, using avisual analog scale and is taken at different predefined times of day,wherein said first plurality of quantitative fullness measurementscollectively define a first area representative of said first state,wherein the second state is defined by a post-stimulation fullnessprofile comprising a second plurality of quantitative fullnessmeasurements, wherein each of said second plurality of quantitativefullness measurements is determined, after stimulation, using saidvisual analog scale and is taken at different predefined times of day,wherein said second plurality of quantitative fullness measurementscollectively define a second area representative of said second state,and wherein said first area differs from said second area by at least5%, thereby representing an increase in the fullness level of thepatient.

Optionally, said plurality of stimulation parameters are defined suchthat, after applying at least one stimulation to the patient's epidermallayer, the patient's appetite modulates from a first state to a secondstate, wherein the patient's appetite in the second state is decreasedrelative to the patient's appetite in the first state, wherein saidfirst state appetite is measured using a scale at predefined times ofday over a first predefined period of time, wherein said second stateappetite is measured, after stimulation is initiated, using said scaleat said predefined times of day over a second predefined period of time,equal in duration to the first predefined period of time, and whereinsaid second state appetite decreases such that it is equal to, or lessthan, 95% of the first state appetite.

Optionally, said plurality of stimulation parameters are defined suchthat, after applying at least one stimulation to the patient's epidermallayer, the patient's hunger modulates from a first state to a secondstate, wherein the patient's hunger in the second state is decreasedrelative to the patient's hunger in the first state, wherein said firststate hunger is measured using a scale at predefined times of day over afirst predefined period of time, wherein said second state hunger ismeasured, after stimulation is initiated, using said scale at saidpredefined times of day over a second predefined period of time, equalin duration to the first predefined period of time, and wherein saidsecond state hunger decreases such that it is equal to, or less than,95% of the first state hunger.

Optionally, said plurality of stimulation parameters are defined suchthat, after applying at least one stimulation to the patient's epidermallayer, the patient's satiety level modulates from a first state to asecond state, wherein the patient's satiety level in the second state isincreased relative to the patient's satiety level in the first state,wherein said first state satiety level is measured using a scale atpredefined times of day over a first predefined period of time, whereinsaid second state satiety level is measured, after stimulation isinitiated, using said scale at said predefined times of day over asecond predefined period of time, equal in duration to the firstpredefined period of time, and wherein said second state satiety levelincreases such that it is equal to, or greater than, 105% of the firststate satiety level.

Optionally, said plurality of stimulation parameters are defined suchthat, after applying at least one stimulation to the patient's epidermallayer, the patient's satiation level modulates from a first state to asecond state, wherein said first state satiation level is measured usinga scale at predefined times of day over a first predefined period oftime, wherein said second state satiation level is measured, afterstimulation is initiated, using said scale at said predefined times ofday over a second predefined period of time, equal in duration to thefirst predefined period of time, and wherein said second state satiationlevel increases such that it is equal to, or greater than, 105% of thefirst state satiation level.

Optionally, said plurality of stimulation parameters are defined suchthat, after applying at least one stimulation to the patient's epidermallayer, the patient's fullness level modulates from a first state to asecond state, wherein said first state fullness level is measured usinga scale at predefined times of day over a first predefined period oftime, wherein said second state fullness level is measured, afterstimulation is initiated, using said scale at said predefined times ofday over a second predefined period of time, equal in duration to thefirst predefined period of time, and wherein said second state fullnesslevel increases such that it is equal to, or greater than, 105% of thefirst state fullness level.

Optionally, said plurality of stimulation parameters are furtherselected such that, after at least one stimulation, an amount of thepatient's antral motility reduces relative to the patient's antralmotility before stimulation.

Optionally, said plurality of stimulation parameters are furtherselected such that, after at least one stimulation, an amount of thepatient's gastric motility reduces relative to the patient's gastricmotility before stimulation.

Optionally, said plurality of stimulation parameters are furtherselected such that, after at least one stimulation, a rate of thepatient's gastric emptying reduces relative to a rate of the patient'sgastric emptying before stimulation.

Optionally, said plurality of stimulation parameters are furtherselected such that, after at least one stimulation, the patient'sappetite decreases, over a predefined period of time, relative to thepatient's appetite before stimulation and a nausea level of the patientdoes not increase, over said predefined period of time, relative to anausea level of the patient before stimulation.

Optionally, said plurality of stimulation parameters are furtherselected such that, after at least one stimulation, the patient's hungerdecreases, over a predefined period of time, relative to the patient'shunger before stimulation and a nausea level of the patient does notincrease, over said predefined period of time, relative to a nausealevel of the patient before stimulation.

Optionally, said plurality of stimulation parameters are furtherselected such that, after at least one stimulation, the patient'ssatiety level increases, over a predefined period of time, relative tothe patient's satiety level before stimulation and a nausea level of thepatient does not increase, over said predefined period of time, relativeto a nausea level of the patient before stimulation.

Optionally, said plurality of stimulation parameters are furtherselected such that, after at least one stimulation, the patient'ssatiation level increases, over a predefined period of time, relative tothe patient's satiation level before stimulation and a nausea level ofthe patient does not increase, over said predefined period of time,relative to a nausea level of the patient before stimulation.

Optionally, said plurality of stimulation parameters are furtherselected such that, after at least one stimulation, the patient'sfullness level increases, over a predefined period of time, relative tothe patient's fullness level before stimulation and a nausea level ofthe patient does not increase, over said predefined period of time,relative to a nausea level of the patient before stimulation.

Optionally, said plurality of stimulation parameters are furtherselected such that, after at least one stimulation, the patient'sappetite decreases, over a predefined period of time, relative to thepatient's appetite before stimulation, wherein at least one of adyspepsia level of the patient or a nausea level of the patient does notincrease, over said predefined period of time, relative to at least oneof a dyspepsia level or a nausea level of the patient beforestimulation, and wherein said at least one stimulation does not causethe patient to experience a pain sensation.

Optionally, said plurality of stimulation parameters are furtherselected such that, after at least one stimulation, the patient's hungerdecreases, over a predefined period of time, relative to the patient'shunger before stimulation, wherein at least one of a dyspepsia level ofthe patient or a nausea level of the patient does not increase, oversaid predefined period of time, relative to at least one of a dyspepsialevel or a nausea level of the patient before stimulation, and whereinsaid at least one stimulation does not cause the patient to experience apain sensation.

Optionally, said plurality of stimulation parameters are furtherselected such that, after at least one stimulation, the patient'ssatiety level increases, over a predefined period of time, relative tothe patient's satiety level before stimulation, wherein at least one ofa dyspepsia level of the patient or a nausea level of the patient doesnot increase, over said predefined period of time, relative to at leastone of a dyspepsia level or a nausea level of the patient beforestimulation, and wherein said at least one stimulation does not causethe patient to experience a pain sensation.

Optionally, said plurality of stimulation parameters are furtherselected such that, after at least one stimulation, the patient'ssatiation level increases, over a predefined period of time, relative tothe patient's satiation level before stimulation, wherein at least oneof a dyspepsia level of the patient or a nausea level of the patientdoes not increase, over said predefined period of time, relative to atleast one of a dyspepsia level or a nausea level of the patient beforestimulation, and wherein said at least one stimulation does not causethe patient to experience a pain sensation.

Optionally, said plurality of stimulation parameters are furtherselected such that, after at least one stimulation, the patient'sfullness level increases, over a predefined period of time, relative tothe patient's fullness level before stimulation, wherein at least one ofa dyspepsia level of the patient or a nausea level of the patient doesnot increase, over said predefined period of time, relative to at leastone of a dyspepsia level or a nausea level of the patient beforestimulation, and wherein said at least one stimulation does not causethe patient to experience a pain sensation.

Optionally, said plurality of stimulation parameters are furtherselected such that, after at least one stimulation, a total body weightof the patient reduces by at least 1% relative to a total body weight ofthe patient before stimulation.

Optionally, said plurality of stimulation parameters are furtherselected such that, after at least one stimulation, an excess bodyweight of the patient reduces by at least 3% relative to an excess bodyweight of the patient before stimulation.

Optionally, said plurality of stimulation parameters are furtherselected such that, after at least one stimulation, a total body weightof the patient reduces by at least 1% relative to a total body weight ofthe patient before stimulation and a well-being level of the patientdoes not reduce more than 5% relative to a well-being level of thepatient before stimulation.

Optionally, said plurality of stimulation parameters are furtherselected such that, after at least one stimulation, an excess bodyweight of the patient reduces by at least 3% relative to an excess bodyweight of the patient before stimulation and a well-being level of thepatient does not reduce more than 5% relative to a well-being level ofthe patient before stimulation.

Optionally, said plurality of stimulation parameters are furtherselected such that, after at least one stimulation, a pre-prandialghrelin level of the patient reduces by at least 3% relative to apre-prandial ghrelin level of the patient before stimulation.

Optionally, said plurality of stimulation parameters are furtherselected such that, after at least one stimulation, a post-prandialghrelin level of the patient reduces by at least 3% relative to apost-prandial ghrelin level of the patient before stimulation.

Optionally, said plurality of stimulation parameters are furtherselected such that, after at least one stimulation session, exerciseoutput of the patient increases by at least 3% relative to the exerciseoutput of the patient before stimulation.

Optionally, said plurality of stimulation parameters are furtherselected such that, after at least one stimulation, a glucagon-likepeptide-1 level of the patient increases by at least 3% relative to aglucagon-like peptide-1 level of the patient before stimulation.

Optionally, said plurality of stimulation parameters are furtherselected such that, after at least one stimulation, a leptin level ofthe patient increases by at least 3% relative to a leptin level of thepatient before stimulation.

Optionally, said plurality of stimulation parameters are furtherselected such that, after at least one stimulation, the patient'sappetite decreases, over a predefined period of time, relative to thepatient's appetite before stimulation and a nausea level of the patientdoes not increase by more than 10%, over said predefined period of time,relative to the nausea level of the patient before stimulation.

Optionally, said plurality of stimulation parameters are furtherselected such that, after at least one stimulation, a peptide YY levelof the patient increases by at least 3% relative to a peptide YY levelof the patient before stimulation.

Optionally, said plurality of stimulation parameters are furtherselected such that, after at least one stimulation, a lipopolysaccharidelevel of the patient reduces by at least 3% relative to alipopolysaccharide level of the patient before stimulation.

Optionally, said plurality of stimulation parameters are furtherselected such that, after at least one stimulation, a motilin-relatedpeptide level of the patient reduces by at least 3% relative to amotilin-related peptide level of the patient before stimulation.

Optionally, said plurality of stimulation parameters are furtherselected such that, after at least one stimulation, a cholecystokininlevel of the patient increases by at least 3% relative to acholecystokinin level of the patient before stimulation.

Optionally, said plurality of stimulation parameters are furtherselected such that, after at least one stimulation, a resting metabolicrate of the patient increases by at least 3% relative to a restingmetabolic rate of the patient before stimulation.

Optionally, said plurality of stimulation parameters are furtherselected such that, after at least one stimulation, a plasma-betaendorphin level of the patient increases by at least 3% relative to aplasma-beta endorphin level of the patient before stimulation.

Optionally, said plurality of stimulation parameters are furtherselected such that, after at least one stimulation, the patient's hungerdecreases, over a predefined period of time, relative to the patient'shunger before stimulation and a nausea level of the patient does notincrease by more than 10%, over said predefined period of time, relativeto the nausea level of the patient before stimulation.

Optionally, said plurality of stimulation parameters are furtherselected such that, after at least one stimulation, the patient'sglucose homeostasis, or balance of insulin and glucagon, improves by atleast 3% relative to the patient's glucose homeostasis beforestimulation.

Optionally, said plurality of stimulation parameters are furtherselected such that, after at least one stimulation, the patient's levelof hemoglobin A1c decreases by an amount equal to at least 0.3%.

Optionally, said plurality of stimulation parameters are furtherselected such that, after at least one stimulation, a triglyceride levelof the patient decreases by at least 3% relative to a triglyceride levelof the patient before stimulation.

Optionally, said plurality of stimulation parameters are furtherselected such that, after at least one stimulation, a total bloodcholesterol level of the patient decreases by at least 3% relative to atotal blood cholesterol level of the patient before stimulation.

Optionally, said plurality of stimulation parameters are furtherselected such that, after at least one stimulation, a glycemia level ofthe patient decreases by at least 3% relative to a glycemia level of thepatient before stimulation.

Optionally, said plurality of stimulation parameters are furtherselected such that, after at least one stimulation, a degree of insulinresistance of the patient improves by at least 3% relative to a degreeof insulin resistance of the patient before stimulation.

Optionally, said plurality of stimulation parameters are furtherselected such that, after at least one stimulation, a composition of thepatient's gut microbiota modulates from a first state to a second state,wherein the first state has a first level of bacteroidetes and a firstlevel of firmicutes, wherein the second state has a second level ofbacteroidetes and a second level of firmicutes, wherein the second levelof bacteroidetes is greater than the first level of bacteroidetes by atleast 3%, and wherein the second level of firmicutes is less than thefirst level of firmicutes by at least 3%.

Optionally, said plurality of electrical pulses comprise a pulse widthin a range of 10 μsec to 100 msec, a pulse amplitude in a range of 100μA to 500 mA, and a pulse frequency in a range of 1 Hz to 10,000 Hz.

Optionally, said plurality of electrical pulses comprise a pulse widthin a range of 10 μsec to 10 msec and a pulse amplitude in a range of 15mA to 30 mA.

Optionally, said plurality of electrical pulses comprise a pulseamplitude in a range of 100 μA to 100 mA.

Optionally, said plurality of electrical pulses comprise a pulse widthin a range of 10 μsec to 100 msec and a pulse amplitude in a range of 5mA to 45 mA.

Optionally, said pulse generator generates an electrical field andwherein the electrical field is adapted to penetrate, via the at leastone electrode, a range of 0.1 mm to 25 mm through the patient'sepidermal layer.

Optionally, said method further comprises: determining a centralelectrical stimulation reaction threshold for the patient; determining aspinal electrical stimulation reaction threshold for the patient;defining at least a portion of the plurality of stimulation parameterssuch that at least one of a pulse width, a pulse amplitude, and a pulsefrequency is set above the spinal electrical stimulation reactionthreshold but below the central electrical stimulation reactionthreshold; and generating said plurality of electrical pulses, whereinsaid plurality of electrical pulses is defined by said pulse width, saidpulse amplitude, and said pulse frequency.

Optionally, said method further comprises: determining a maximumtolerable electrical stimulation reaction threshold for the patient;determining a spinal electrical stimulation reaction threshold for thepatient; defining at least a portion of the plurality of stimulationparameters such that at least one of a pulse width, a pulse amplitude,and a pulse frequency is set above the spinal electrical stimulationreaction threshold but below the maximum tolerable electricalstimulation reaction threshold; and generating said plurality ofelectrical pulses, wherein said plurality of electrical pulses isdefined by said pulse width, said pulse amplitude, and said pulsefrequency.

Optionally, the method further comprises: determining a centralelectrical stimulation reaction threshold for the patient; defining atleast a portion of the plurality of stimulation parameters such that atleast one of a pulse width, a pulse amplitude, and a pulse frequency isset below the central electrical stimulation reaction threshold; andgenerating said plurality of electrical pulses, wherein said pluralityof electrical pulses is defined by said pulse width, said pulseamplitude, and said pulse frequency.

Optionally, the method further comprises determining a maximum tolerableelectrical stimulation reaction threshold for the patient; defining atleast a portion of the plurality of stimulation parameters such that atleast one of a pulse width, a pulse amplitude, and a pulse frequency isset below the maximum tolerable electrical stimulation reactionthreshold; and generating said plurality of electrical pulses, whereinsaid plurality of electrical pulses is defined by said pulse width, saidpulse amplitude, and said pulse frequency.

Optionally, the method further comprises determining a placement for theelectrical dermal patch on the patient by finding a midclavicular lineof the patient, progressing downward from the midclavicular line to abottom rib of a thoracic cage of the patient, moving further downwardfrom the bottom rib to identify a placement spot, and placing a topcenter portion of the electrical dermal patch at the placement spot.

Optionally, the move further downward from the bottom rib to identify aplacement spot is in a range of 1 cm to 6 cm.

Optionally, the method further comprises generating said plurality ofelectrical pulses such that at least one of the patient's C5, C6, C7,C8, T1, T2, T3, T4, T5, T6, T7, T8, T9, T10, T11, and T12 dermatomes iselectrically stimulated.

Optionally, said method further comprises generating said plurality ofelectrical pulses such that at least one of the patient's C5, C6, C7,C8, T1, T2, T3, T4, T5, T6, T7, T8, T9, T10, T11, and T12 frontal andlateral dermatomes is electrically stimulated while, concurrent thereto,no portion of the patient's C5, C6, C7, C8, T1, T2, T3, T4, T5, T6, T7,T8, T9, T10, T11, and T12 posterior dermatomes is electricallystimulated.

Optionally, said method further comprises generating said plurality ofelectrical pulses such that at least one of the patient's C5, C6, C7,C8, T1, T2, T3, T4, T5, T6, T7, T8, T9, T10, T11, and T12 frontal andlateral dermatomes is electrically stimulated while, concurrent thereto,no portion of the patient's C5, C6, C7, C8, T1, T2, T3, T4, T5, T6, T7,T8, T9, T10, T11, or T12 posterior dermatomes is electricallystimulated.

Optionally, the method further comprises generating said plurality ofelectrical pulses such that at least one of the patient's C8 anterior orposterior dermatome located on the patient's hand, wrist, elbow, andfingers, C8 anterior or posterior dermatome located on the patient'sarm, C8 dermatome located on the patient's upper trunk, T1 anterior orposterior dermatome located on the patient's arm, T1 anterior orposterior dermatome located on the patient's wrist, elbow, and hand, andT1 anterior or posterior dermatome located on the patient's upper trunkis electrically stimulated.

Optionally, the method further comprises generating said plurality ofelectrical pulses such that at least one of the patient's T2 frontal andlateral thoracic dermatome, T3 frontal and lateral thoracic dermatome,T4 frontal and lateral thoracic dermatome, T5 frontal and lateralthoracic dermatome, T6 frontal and lateral thoracic dermatome, T7frontal and lateral thoracic dermatome, T8 frontal and lateral thoracicdermatome, T9 frontal and lateral thoracic dermatome, and T10 frontaland lateral thoracic dermatome is electrically stimulated and any one ofthe patient's T2 posterior thoracic dermatome, T3 posterior thoracicdermatome, T4 posterior thoracic dermatome, T5 posterior thoracicdermatome, T6 posterior thoracic dermatome, T7 posterior thoracicdermatome, T8 posterior thoracic dermatome, T9 posterior thoracicdermatome, and T10 posterior thoracic dermatome is not electricallystimulated.

Optionally, the method further comprises generating said plurality ofelectrical pulses such that at least one of the patient's T2 frontal andlateral thoracic dermatome, T3 frontal and lateral thoracic dermatome,T4 frontal and lateral thoracic dermatome, T5 frontal and lateralthoracic dermatome, T6 frontal and lateral thoracic dermatome, T7frontal and lateral thoracic dermatome, T8 frontal and lateral thoracicdermatome, T9 frontal and lateral thoracic dermatome, or T10 frontal andlateral thoracic dermatome is electrically stimulated.

Optionally, the method further comprises causing an application to beinstalled on an external device, wherein said application is configuredto acquire patient status data and to prompt, via said application, thepatient to input said patient status data; using said application togenerate a modulation signal based upon said patient status data,wherein said modulation signal comprises instructions for modulating atleast one of the plurality of stimulation parameters, wherein saidplurality of stimulation parameters comprise at least one of a pulsewidth, a pulse amplitude, a pulse frequency, a pulse shape, a dutycycle, a session duration, and a session frequency; using saidapplication to wirelessly transmit said modulation signal from theexternal device to the electrical dermal patch; receiving saidmodulation signal at the electrical dermal patch; in said electricaldermal patch, using the modulation signal to modify at least one of saidpulse width, pulse amplitude, pulse frequency, pulse shape, duty cycle,session duration, and session frequency to yield a first pulse width, afirst pulse amplitude, a first pulse frequency, a first pulse shape, afirst duty cycle, a first session duration, or a first sessionfrequency; and in said electrical dermal patch, using the first pulsewidth, the first pulse amplitude, the first pulse frequency, the firstpulse shape, the first duty cycle, the first session duration, or thefirst session frequency to generate said plurality of electrical pulses.

Optionally, said patient status data comprises at least one of a degreeof hunger being experienced by the patient, a degree of appetite beingexperienced by the patient, a satiety level being experienced by thepatient, a satiation level being experienced by the patient, a degree ofdyspepsia being experienced by the patient, a degree of nausea beingexperienced by the patient and a degree of well-being being experiencedby the patient.

Optionally, the method further comprises acquiring, via saidapplication, a first stimulation protocol; and using said firststimulation protocol, within said application, to generate themodulation signal.

Optionally, the method further comprises acquiring, via saidapplication, a second stimulation protocol, wherein said secondstimulation protocol is different from the first stimulation protocol;using said second stimulation protocol, within said application, togenerate a second modulation signal, wherein said second modulationsignal comprises instructions for modulating at least one of the pulsewidth, the pulse amplitude, the pulse frequency, the pulse shape, theduty cycle, the session duration, and the session frequency; causing,via said application, said second modulation signal to be wirelesslytransmitted from the external device to the electrical dermal patch; andreceiving said second modulation signal at the electrical dermal patch;in said electrical dermal patch, using the second modulation signal tomodify at least one of said pulse width, pulse amplitude, pulsefrequency, pulse shape, duty cycle, session duration, and sessionfrequency to yield at least one second pulse width, a second pulseamplitude, a second pulse frequency, a second pulse shape, a second dutycycle, a second session duration, and a second session frequency.

Optionally, the second pulse width is different from the first pulsewidth, wherein the electrical dermal patch uses the second pulse widthto generate a second plurality of electrical pulses, and wherein theelectrical dermal patch applies a stimulation to the patient's epidermallayer using said second plurality of electrical pulses.

Optionally, the second pulse amplitude is different from the first pulseamplitude, wherein the electrical dermal patch uses the second pulseamplitude to generate a second plurality of electrical pulses, andwherein the electrical dermal patch applies a stimulation to thepatient's epidermal layer using said second plurality of electricalpulses.

Optionally, the second pulse frequency is different from the first pulsefrequency, wherein the electrical dermal patch uses the second pulsefrequency to generate a second plurality of electrical pulses, andwherein the electrical dermal patch applies a stimulation to thepatient's epidermal layer using said second plurality of electricalpulses.

Optionally, the second pulse shape is different from the first pulseshape, wherein the electrical dermal patch uses the second pulse shapeto generate a second plurality of electrical pulses, and wherein theelectrical dermal patch applies a stimulation to the patient's epidermallayer using said second plurality of electrical pulses.

Optionally, the second duty cycle is different from the first dutycycle, wherein the electrical dermal patch uses the second duty cycle togenerate a second plurality of electrical pulses, and wherein theelectrical dermal patch applies a stimulation to the patient's epidermallayer using said second plurality of electrical pulses.

Optionally, the second session duration is different from the firstsession duration, wherein the electrical dermal patch uses the secondsession duration to generate a second plurality of electrical pulses,and wherein the electrical dermal patch applies a stimulation to thepatient's epidermal layer using said second plurality of electricalpulses.

Optionally, the second session frequency is different from the firstsession frequency, wherein the electrical dermal patch uses the secondsession frequency to generate a second plurality of electrical pulses,and wherein the electrical dermal patch applies a stimulation to thepatient's epidermal layer using said second plurality of electricalpulses.

Optionally, the method further comprises prompting, via an applicationinstalled on an external device, a user to input data; generating asignal based upon said data; causing said signal to be wirelesslytransmitted from the external device to the electrical dermal patch;receiving said signal at the electrical dermal patch; and using saidsignal to modify at least one of said plurality of stimulationparameters, wherein said plurality of stimulation parameters comprise atleast one of a pulse width, a pulse amplitude, a pulse frequency, apulse shape, a duty cycle, a session duration, and a session frequency.

Optionally, said signal is generated based upon data inputted by theuser and a plurality of values, each of said plurality of valuesrepresents a maximum numerical limit or minimum numerical limit to atleast one of the pulse width, the pulse amplitude, the pulse frequency,the pulse shape, the duty cycle, the session duration, and the sessionfrequency.

Optionally, the method further comprises using an application installedon an external device to acquire patient status data over a period oftime, said patient status data including at least one of the appetite ofthe patient, the hunger of the patient, a level of well-being of thepatient, a level of nausea of the patient, an amount of the patient'sweight, an amount of calories consumed by the patient, and an amount ofcalories expended by the patient; after said period of time, generatinga signal based upon said patient status data; causing the signal to bewirelessly transmitted to the electrical dermal patch; and, causing theplurality of electrical pulses to be generated using a second pluralityof stimulation parameters, wherein said second plurality of stimulationparameters is determined based upon said signal and wherein said secondplurality of stimulation parameters has at least one stimulationparameter that is different than at least one of the plurality ofstimulation parameters.

Optionally, if the level of the appetite is above a threshold level, thesecond plurality of stimulations has at least one of a pulse width, apulse amplitude, a pulse frequency, a pulse duty cycle, a pulse shape, asession duration, or a session frequency that is increased relative toat least one of a pulse width, a pulse amplitude, a pulse frequency, apulse duty cycle, a pulse shape, a session duration, or a sessionfrequency of the plurality of stimulation parameters.

Optionally, if the level of the appetite is below a threshold level, thesecond plurality of stimulations has at least one of a pulse width, apulse amplitude, a pulse frequency, a pulse duty cycle, a pulse shape, asession duration, or a session frequency that is decreased relative toat least one of a pulse width, a pulse amplitude, a pulse frequency, apulse duty cycle, a pulse shape, a session duration, or a sessionfrequency of the plurality of stimulation parameters.

Optionally, if the level of nausea is above a threshold level, thesecond plurality of stimulations has at least one of a pulse width, apulse amplitude, a pulse frequency, a pulse duty cycle, a pulse shape, asession duration, or a session frequency that is decreased relative toat least one of a pulse width, a pulse amplitude, a pulse frequency, apulse duty cycle, a pulse shape, a session duration, or a sessionfrequency of the plurality of stimulation parameters.

Optionally, if the level of the hunger is above a threshold level, thesecond plurality of stimulations has at least one of a pulse width, apulse amplitude, a pulse frequency, a pulse duty cycle, a pulse shape, asession duration, or a session frequency that is increased relative toat least one of a pulse width, a pulse amplitude, a pulse frequency, apulse duty cycle, a pulse shape, a session duration, or a sessionfrequency of the plurality of stimulation parameters.

Optionally, if the level of hunger is below a threshold level, thesecond plurality of stimulations has at least one of a pulse width, apulse amplitude, a pulse frequency, a pulse duty cycle, a pulse shape, asession duration, or a session frequency that is decreased relative toat least one of a pulse width, a pulse amplitude, a pulse frequency, apulse duty cycle, a pulse shape, a session duration, or a sessionfrequency of the plurality of stimulation parameters.

In some embodiments, the present specification discloses a method ofenabling a person to comply with a diet plan comprising: providing anelectrical dermal patch adapted to adhere to the person's epidermallayer, wherein said electrical dermal patch comprises a controller, atleast one electrode adapted to be in electrical contact with saidpatient's epidermal layer, and a pulse generator in electricalcommunication with the controller and said at least one electrode;generating a plurality of electrical pulses having a treatment sessionduration and a treatment session frequency, wherein each of saidplurality of electrical pulses is defined by a pulse width, a pulseamplitude, a pulse shape, a pulse frequency and wherein said pulseshape, pulse width, said pulse amplitude, and said pulse frequency areselected to enable the person to comply with the diet plan; using anapplication installed on an external device to acquire data over aperiod of time, said data including at least one of a timing of caloricconsumption, an amount of caloric consumption, and a content of acaloric consumption; after said period of time, generating a signal,using said application, based upon said data; causing the signal to betransmitted to the electrical dermal patch; and generating a secondplurality of electrical pulses using a plurality of stimulationparameters, said plurality of stimulation parameters being determinedbased upon said signal and including at least one of a second pulsewidth, a second pulse amplitude, a second pulse frequency, a secondpulse duty cycle, a second pulse shape, a second treatment sessionduration, and a second treatment session frequency.

Optionally, the epidermal layer is positioned within a range of 0.1 mmto 25 mm from at least one of the person's C5, C6, C7, C8, T1, T2, T3,T4, T5, T6, T7, T8, T9, T10, T11, and T12 dermatomes.

Optionally, if the amount of caloric consumption varies from apredefined amount, the second pulse width is greater than the pulsewidth.

Optionally, if the amount of caloric consumption varies from apredefined amount, the second pulse amplitude is greater than the pulseamplitude.

Optionally, if the amount of caloric consumption varies from apredefined amount, the second pulse frequency is greater than the pulsefrequency.

Optionally, if the amount of caloric consumption varies from apredefined amount, the second treatment session duration is greater thanthe treatment session duration.

Optionally, if the amount of caloric consumption varies from apredefined amount, the second treatment session frequency is greaterthan the treatment session frequency.

Optionally, the content of a caloric consumption includes at least oneof an amount of carbohydrates, an amount of protein, an amount of fat,an amount of sugar, an amount of vitamins, an amount of minerals, and anamount of glycemic index.

Optionally, if at least one of the amount of carbohydrates, the amountof fat, the amount of sugar, and the amount of glycemic index variesfrom a predefined amount, the second pulse width is greater than thepulse width.

Optionally, if at least one of the amount of carbohydrates, the amountof fat, the amount of sugar, and the amount of glycemic index variesfrom a predefined amount, the second pulse amplitude is greater than thepulse amplitude.

Optionally, if at least one of the amount of carbohydrates, the amountof fat, the amount of sugar, and the amount of glycemic index variesfrom a predefined amount, the second pulse frequency is greater than thepulse frequency.

Optionally, if at least one of the amount of carbohydrates, the amountof fat, the amount of sugar, and the amount of glycemic index variesfrom a predefined amount, the second treatment session duration isgreater than the treatment session duration.

Optionally, if at least one of the amount of carbohydrates, the amountof fat, the amount of sugar, and the amount of glycemic index variesfrom a predefined amount, the second treatment session frequency isgreater than the treatment session frequency.

In some embodiments, the present specification discloses a method ofenabling a person to comply with a diet plan comprising: providing anelectrical dermal patch adapted to adhere to the person's epidermallayer, wherein said electrical dermal patch comprises a controller, atleast one electrode adapted to be in electrical contact with saidpatient's epidermal layer, and a pulse generator in electricalcommunication with the controller and said at least one electrode; usingsaid electrical dermal patch, generating a plurality of electricalpulses at a first predefined time of day; using an application installedon a device separate from said electrical dermal patch to acquire dataover a period of time, said data including at least one of a timing ofcaloric consumption and an amount of caloric consumption; after saidperiod of time, generating a signal, using said application, based uponsaid data; causing the signal to be transmitted to the electrical dermalpatch; and generating a second plurality of electrical pulses using aplurality of stimulation parameters, said plurality of stimulationparameters being determined based upon said signal and including asecond predefined time of day.

Optionally, the epidermal layer is positioned within a range of 0.1 mmto 25 mm from at least one of the person's C5, C6, C7, C8, T1, T2, T3,T4, T5, T6, T7, T8, T9, T10, T11, and T12 dermatomes.

Optionally, if the amount of caloric consumption varies from apredefined amount, the second plurality of electrical pulses aregenerated at the second predefined time of day, wherein the secondpredefined time of day is different from the first predefined time ofday and is based on the timing of caloric consumption.

Optionally, the data further includes at least one of an amount ofcarbohydrates consumed by the person, an amount of fat consumed by theperson, and an amount of sugar consumed by the person.

Optionally, if the amount of carbohydrates varies from a predefinedamount, the second plurality of electrical pulses are generated at thesecond predefined time of day, wherein the second predefined time of dayis different from the first predefined time of day and is based on thetiming of caloric consumption.

Optionally, if the amount of fat varies from a predefined amount, thesecond plurality of electrical pulses are generated at the secondpredefined time of day, wherein the second predefined time of day isdifferent from the first predefined time of day and is based on thetiming of caloric consumption.

Optionally, if the amount of sugar varies from a predefined amount, thesecond plurality of electrical pulses are generated at the secondpredefined time of day, wherein the second predefined time of day isdifferent from the first predefined time of day and is based on thetiming of caloric consumption.

Optionally, the electrical dermal patch further comprises a transceiverand wherein said signal is caused to be transmitted to the electricaldermal patch wirelessly.

Optionally, the device is at least one of a mobile phone, a tabletcomputer, and a laptop computer.

In some embodiments, the present specification discloses a method ofenabling a person to comply with a diet plan, said diet plan having atleast one of a recommended timing of caloric consumption, a recommendedcontent of caloric consumption, and a recommended amount of caloricconsumption, comprising: providing an electrical dermal patch adapted toadhere to the person's epidermal layer, wherein said electrical dermalpatch comprises a controller, at least one electrode adapted to be inelectrical contact with said patient's epidermal layer, and a pulsegenerator in electrical communication with the controller and said atleast one electrode; generating a plurality of electrical pulses at afirst predefined time of day wherein said plurality of electrical pulsesare defined by at least one of a pulse width, a pulse amplitude, a pulsefrequency, a duty cycle, a pulse shape, a treatment session duration,and a treatment session frequency; using an application installed on adevice separate from said electrical dermal patch to acquire data over aperiod of time, said data including at least one of a timing of caloricconsumption, a content of caloric consumption, and an amount of caloricconsumption; using said application to compare at least one of thetiming of caloric consumption, the content of caloric consumption, andthe amount of caloric consumption with at least one of the recommendedtiming of caloric consumption, recommended content of caloricconsumption, and recommended amount of caloric consumption; generating asignal, using said application, based upon said comparison; causing thesignal to be transmitted to the electrical dermal patch; and, generatinga second plurality of electrical pulses using a plurality of stimulationparameters, said plurality of stimulation parameters being determinedbased upon said signal and including at least one of a second pulsewidth, a second pulse amplitude, a second pulse frequency, a secondpulse duty cycle, a second pulse shape, a second treatment sessionduration, a second treatment session frequency, and a second predefinedtime of day.

Optionally, if the amount of caloric consumption varies from therecommended amount of caloric consumption by a predefined amount, thesecond pulse width is greater than the pulse width.

Optionally, if the amount of caloric consumption varies from therecommended amount of caloric consumption by a predefined amount, thesecond pulse amplitude is greater than the pulse amplitude.

Optionally, if the amount of caloric consumption varies from therecommended amount of caloric consumption by a predefined amount, thesecond pulse frequency is greater than the pulse frequency.

Optionally, if the amount of caloric consumption varies from therecommended amount of caloric consumption by a predefined amount, thesecond treatment session duration is greater than the treatment sessionduration.

Optionally, if the amount of caloric consumption varies from therecommended amount of caloric consumption by a predefined amount, thesecond treatment session frequency is greater than the treatment sessionfrequency.

Optionally, the content of a caloric consumption includes at least oneof an amount of carbohydrates, an amount of fat, an amount of sugar, andan amount of glycemic index.

Optionally, if at least one of the amount of carbohydrates, the amountof fat, the amount of sugar, and the amount of glycemic index variesfrom the recommended content of caloric consumption by a predefinedamount, the second pulse width is greater than the pulse width.

Optionally, if at least one of the amount of carbohydrates, the amountof fat, the amount of sugar, and the amount of glycemic index variesfrom the recommended content of caloric consumption by a predefinedamount, the second pulse amplitude is greater than the pulse amplitude.

Optionally, if at least one of the amount of carbohydrates, the amountof fat, the amount of sugar, and the amount of glycemic index variesfrom the recommended content of caloric consumption by a predefinedamount, the second pulse frequency is greater than the pulse frequency.

Optionally, if at least one of if the amount of carbohydrates, theamount of fat, the amount of sugar, and the amount of glycemic indexvaries from the recommended content of caloric consumption by apredefined amount, the second treatment session duration is greater thanthe treatment session duration.

Optionally, if at least one of the amount of carbohydrates, the amountof fat, the amount of sugar, and the amount of glycemic index variesfrom the recommended content of caloric consumption by a predefinedamount, the second treatment session frequency is greater than thetreatment session frequency.

Optionally, the electrical dermal patch further comprises a transceiverand wherein said signal is caused to be transmitted to the electricaldermal patch wirelessly.

Optionally, said device is at least one of a mobile phone, a tabletcomputer, and a laptop computer.

In some embodiments, the present specification discloses a method ofusing an electrical dermal patch, adhered to a person's epidermal layer,to enable the person to comply with a diet plan, said diet plan beingdefined by at least one of a recommended timing of caloric consumption,a recommended content of caloric consumption, and a recommended amountof caloric consumption, comprising: generating a plurality of electricalpulses at a first predefined time of day, wherein said plurality ofelectrical pulses are defined by at least one of a pulse width, a pulseamplitude, a pulse frequency, a pulse duty cycle, a pulse shape, atreatment session duration, and a treatment session frequency; receivingdata into an application installed on a device separate from saidelectrical dermal patch, said data including at least one of a timing ofcaloric consumption, a content of caloric consumption, and an amount ofcaloric consumption; using the application to compare at least one ofthe timing of caloric consumption, the content of caloric consumption,and the amount of caloric consumption with at least one of therecommended timing of caloric consumption, recommended content ofcaloric consumption, and recommended amount of caloric consumption;generating a signal, using said application, based upon said comparison;causing the signal to be transmitted to the electrical dermal patch; andgenerating a second plurality of electrical pulses using a plurality ofstimulation parameters, said plurality of stimulation parameters beingdetermined based upon said signal and including at least one of a secondpulse width, a second pulse amplitude, a second pulse frequency, asecond pulse duty cycle, a second pulse shape, a second treatmentsession duration, a second treatment session frequency, and a secondpredefined time of day.

Optionally, if the amount of caloric consumption varies from therecommended amount of caloric consumption by a predefined amount, thesecond pulse width is greater than the pulse width.

Optionally, if the amount of caloric consumption varies from therecommended amount of caloric consumption by a predefined amount, thesecond pulse amplitude is greater than the pulse amplitude.

Optionally, if the amount of caloric consumption varies from therecommended amount of caloric consumption by a predefined amount, thesecond pulse frequency is greater than the pulse frequency.

Optionally, if the amount of caloric consumption varies from therecommended amount of caloric consumption by a predefined amount, thesecond treatment session duration is greater than the treatment sessionduration.

Optionally, if the amount of caloric consumption varies from therecommended amount of caloric consumption by a predefined amount, thesecond treatment session frequency is greater than the treatment sessionfrequency.

Optionally, if the amount of caloric consumption varies from therecommended amount of caloric consumption by a predefined amount, thesecond pulse width is less than the pulse width.

Optionally, if the amount of caloric consumption varies from therecommended amount of caloric consumption by a predefined amount, thesecond pulse amplitude is less than the pulse amplitude.

Optionally, if the amount of caloric consumption varies from therecommended amount of caloric consumption by a predefined amount, thesecond pulse frequency is less than the pulse frequency.

Optionally, if the amount of caloric consumption varies from therecommended amount of caloric consumption by a predefined amount, thesecond treatment session duration is less than the treatment sessionduration.

Optionally, if the amount of caloric consumption varies from therecommended amount of caloric consumption by a predefined amount, thesecond treatment session frequency is less than the treatment sessionfrequency.

Optionally, the content of a caloric consumption includes at least oneof an amount of carbohydrates, an amount of fat, an amount of sugar, andan amount of glycemic index.

Optionally, if at least one of the amount of carbohydrates, the amountof fat, the amount of sugar, or the amount of glycemic index varies fromthe recommended content of caloric consumption by a predefined amount,the second pulse width is greater than the pulse width.

Optionally, if the amount of carbohydrates, the amount of fat, theamount of sugar, or the amount of glycemic index varies from therecommended content of caloric consumption by a predefined amount, thesecond pulse amplitude is greater than the pulse amplitude.

Optionally, if the amount of carbohydrates, the amount of fat, theamount of sugar, or the amount of glycemic index varies from therecommended content of caloric consumption by a predefined amount, thesecond pulse frequency is greater than the pulse frequency.

Optionally, if the amount of carbohydrates, the amount of fat, theamount of sugar, or the amount of glycemic index varies from therecommended content of caloric consumption by a predefined amount, thesecond treatment session duration is greater than the treatment sessionduration.

Optionally, if the amount of carbohydrates, the amount of fat, theamount of sugar, or the amount of glycemic index varies from therecommended content of caloric consumption by a predefined amount, thesecond treatment session frequency is greater than the treatment sessionfrequency.

Optionally, if at least one of the amount of carbohydrates, the amountof fat, the amount of sugar, or the amount of glycemic index varies fromthe recommended content of caloric consumption by a predefined amount,the second pulse width is less than the pulse width.

Optionally, if the amount of carbohydrates, the amount of fat, theamount of sugar, or the amount of glycemic index varies from therecommended content of caloric consumption by a predefined amount, thesecond pulse amplitude is less than the pulse amplitude.

Optionally, if the amount of carbohydrates, the amount of fat, theamount of sugar, or the amount of glycemic index varies from therecommended content of caloric consumption by a predefined amount, thesecond pulse frequency is less than the pulse frequency.

Optionally, if the amount of carbohydrates, the amount of fat, theamount of sugar, or the amount of glycemic index varies from therecommended content of caloric consumption by a predefined amount, thesecond treatment session duration is less than the treatment sessionduration.

Optionally, if the amount of carbohydrates, the amount of fat, theamount of sugar, or the amount of glycemic index varies from therecommended content of caloric consumption by a predefined amount, thesecond treatment session frequency is less than the treatment sessionfrequency.

Optionally, the electrical dermal patch further comprises a transceiverand wherein said signal is caused to be transmitted to the electricaldermal patch wirelessly.

Optionally, said device is at least one of a mobile phone, a tabletcomputer, and a laptop computer.

In some embodiments, the present specification discloses a method ofusing an electrical dermal patch, adhered to an epidermal layer of apatient, to enable the patient to comply with a diet plan in order toachieve a target weight, comprising: generating a plurality ofelectrical pulses, wherein said plurality of electrical pulses isdefined by at least one of a pulse width, a pulse amplitude, a pulseshape, a pulse frequency, a treatment session duration, and a treatmentsession frequency; using an application installed on a device externalto said electrical dermal patch to acquire patient status data, saidpatient status data including data indicative of a weight of thepatient; comparing the weight of the patient to the target weight;generating a signal, using said application, based upon said comparison;causing the signal to be transmitted to the electrical dermal patch;and, generating a second plurality of electrical pulses using aplurality of stimulation parameters, said plurality of stimulationparameters being determined based upon said signal and including atleast one of a second pulse width, a second pulse shape, a second pulseamplitude, a second pulse frequency, a second treatment sessionduration, and a second treatment session frequency.

Optionally, if the weight of the patient is equal to or less than thetarget weight, at least one of the second pulse width, the second pulseamplitude, the second pulse frequency, the second treatment sessionduration, and the second treatment session frequency is decreasedrelative to at least one of the pulse width, the pulse amplitude, thepulse frequency, the treatment session duration, and the treatmentsession frequency.

Optionally, if the weight of the patient is greater than the targetweight, at least one of the second pulse width, the second pulseamplitude, the second pulse frequency, the second treatment sessionduration, and the second treatment session frequency is increasedrelative to at least one of the pulse width, the pulse amplitude, thepulse frequency, the treatment session duration, and the treatmentsession frequency.

Optionally, the electrical dermal patch further comprises a transceiverand wherein said signal is caused to be transmitted to the electricaldermal patch wirelessly.

Optionally, said device is at least one of a mobile phone, a tabletcomputer, and a laptop computer.

In some embodiments, the present specification discloses a method ofusing an electrical dermal patch, adhered to an epidermal layer of aperson, to enable the person to comply with a diet plan in order toachieve a target weight, comprising: generating, via said electricaldermal patch, a plurality of electrical pulses, wherein said pluralityof electrical pulses is defined by at least one of a pulse width, apulse amplitude, a pulse frequency, a treatment session duration, and atreatment session frequency; using an application installed on a deviceseparate from the electrical dermal patch to acquire data, said databeing indicative of at least one of an appetite of the person, a hungerof the person, a satiety level of the person, a satiation level of theperson, and a fullness level of the person; generating a signal, usingsaid application, based upon said data; causing the signal to betransmitted to the electrical dermal patch; and, generating a secondplurality of electrical pulses using a plurality of stimulationparameters, said plurality of stimulation parameters being determinedbased upon said signal and including at least one of a second pulsewidth, a second pulse amplitude, a second pulse frequency, a secondtreatment session duration, and a second treatment session frequency.

Optionally, if the appetite of the person varies from a target appetitelevel by a predefined amount, at least one of the second pulse width,the second pulse amplitude, the second pulse frequency, the secondtreatment session duration, and the second treatment session frequencyis increased relative to the pulse width, the pulse amplitude, the pulsefrequency, the treatment session duration, and a second treatmentsession frequency.

Optionally, if the hunger of the person varies from a target hungerlevel by a predefined amount, at least one of the second pulse width,the second pulse amplitude, the second pulse frequency, the secondtreatment session duration, and the second treatment session frequencyis increased relative to the pulse width, the pulse amplitude, the pulsefrequency, the treatment session duration, and a second treatmentsession frequency.

Optionally, if the satiety level of the person varies from a targetsatiety level by a predefined amount, at least one of the second pulsewidth, the second pulse amplitude, the second pulse frequency, thesecond treatment session duration, and the second treatment sessionfrequency is increased relative to the pulse width, the pulse amplitude,the pulse frequency, the treatment session duration, and a secondtreatment session frequency.

Optionally, if the satiation level of the person varies from a targetsatiation level by a predefined amount, at least one of the second pulsewidth, the second pulse amplitude, the second pulse frequency, thesecond treatment session duration, and the second treatment sessionfrequency is increased relative to the pulse width, the pulse amplitude,the pulse frequency, the treatment session duration, and a secondtreatment session frequency.

Optionally, if the fullness level of the person varies from a targetfullness level by a predefined amount, at least one of the second pulsewidth, the second pulse amplitude, the second pulse frequency, thesecond treatment session duration, and the second treatment sessionfrequency is increased relative to the pulse width, the pulse amplitude,the pulse frequency, the treatment session duration, and a secondtreatment session frequency.

Optionally, if the appetite of the person varies from a target appetitelevel by a predefined amount, at least one of the second pulse width,the second pulse amplitude, the second pulse frequency, the secondtreatment session duration, and the second treatment session frequencyis decreased relative to the pulse width, the pulse amplitude, the pulsefrequency, the treatment session duration, and a second treatmentsession frequency.

Optionally, if the hunger of the person varies from a target hungerlevel by a predefined amount, at least one of the second pulse width,the second pulse amplitude, the second pulse frequency, the secondtreatment session duration, and the second treatment session frequencyis decreased relative to the pulse width, the pulse amplitude, the pulsefrequency, the treatment session duration, and a second treatmentsession frequency.

Optionally, if the satiety level of the person varies from a targetsatiety level by a predefined amount, at least one of the second pulsewidth, the second pulse amplitude, the second pulse frequency, thesecond treatment session duration, and the second treatment sessionfrequency is decreased relative to the pulse width, the pulse amplitude,the pulse frequency, the treatment session duration, and a secondtreatment session frequency.

Optionally, if the satiation level of the person varies from a targetsatiation level by a predefined amount, at least one of the second pulsewidth, the second pulse amplitude, the second pulse frequency, thesecond treatment session duration, and the second treatment sessionfrequency is decreased relative to the pulse width, the pulse amplitude,the pulse frequency, the treatment session duration, and a secondtreatment session frequency.

Optionally, if the fullness level of the person varies from a targetfullness level by a predefined amount, at least one of the second pulsewidth, the second pulse amplitude, the second pulse frequency, thesecond treatment session duration, and the second treatment sessionfrequency is decreased relative to the pulse width, the pulse amplitude,the pulse frequency, the treatment session duration, and a secondtreatment session frequency.

Optionally, the electrical dermal patch further comprises a transceiverand wherein said signal is caused to be transmitted to the electricaldermal patch wirelessly.

Optionally, said device is at least one of a mobile phone, a tabletcomputer, and a laptop computer.

In some embodiments, the present specification discloses a method ofmodulating at least one of a person's appetite, hunger, satiety level,or satiation comprising: providing an electrical dermal patch adapted toadhere to the person's epidermal layer, wherein said electrical dermalpatch comprises a controller, at least one electrode adapted to be inelectrical contact with said person's epidermal layer, and a pulsegenerator in electrical communication with the controller and said atleast one electrode; defining a first plurality of stimulationparameters; generating a plurality of electrical pulses using said firstplurality of stimulation parameters, wherein said first plurality ofstimulation parameters are defined such that, after applying at leastone stimulation to the patient's epidermal layer, at least one of thepatient's appetite, hunger, satiety level, and satiation level ismodified; using an application installed on a device separate from theelectrical dermal patch to acquire data, said data being indicative ofat least one of the person's appetite, hunger, satiety level, satiationlevel, fullness level, amount of caloric intake, weight, type of caloricintake, and timing of caloric intake; generating a signal, using saidapplication, based upon said data; causing the signal to be transmittedto the electrical dermal patch; and generating a second plurality ofelectrical pulses using a second plurality of stimulation parameters,wherein said second plurality of stimulation parameters is determined.

Optionally, said first plurality of stimulation parameters and secondplurality of stimulation parameters are further selected such that apost-stimulation daily caloric intake of said person decreases relativeto a pre-stimulation daily caloric intake of said person, wherein saidpre-stimulation daily caloric intake is a function of an amount ofcalories consumed by the person over a first predefined period of timeprior to stimulation, and wherein said post-stimulation daily caloricintake is a function of an amount of calories consumed by the personover a second predefined period of time equal in duration to the firstpredefined period of time, after stimulation is initiated.

Optionally, said first plurality of stimulation parameters and secondplurality of stimulation parameters are further selected such that apost-stimulation daily caloric intake of said person is less than 99% ofa pre-stimulation daily caloric intake of said person, wherein saidpre-stimulation daily caloric intake is a function of an amount ofcalories consumed by the person over a first predefined period of timeprior to stimulation, and wherein said post-stimulation daily caloricintake is a function of an amount of calories consumed by the personover a second predefined period of time equal in duration to the firstpredefined period of time, after stimulation is initiated.

Optionally, said first plurality of stimulation parameters and secondplurality of stimulation parameters are further selected such that,after at least one stimulation, the person's compliance with a targetdaily caloric intake increases relative to the person's compliance withthe target daily caloric intake before stimulation.

Optionally, said first plurality of stimulation parameters and secondplurality of stimulation parameters are further selected such that,after at least one stimulation, the person's daily caloric intakedecreases to a range of 600 to 1600 calories from a daily caloric intakerange greater than 1600 calories.

Optionally, said first plurality of stimulation parameters and secondplurality of stimulation parameters are further selected such that,after at least one stimulation, the person's daily caloric intakedecreases from over 2000 calories per day to under 2000 calories perday.

Optionally, said first plurality of electrical pulses and secondplurality of electrical pulses comprise pulse widths in a range of 10μsec to 100 msec, pulse amplitudes in a range of 100 μA to 500 mA, andpulse frequencies in a range of 1 Hz to 10,000 Hz.

Optionally, said first plurality of stimulation parameters and saidsecond plurality of stimulation parameters are further selected suchthat, after at least one stimulation, a total body weight of the personreduces by at least 1% relative to a total body weight of the personbefore stimulation.

Optionally, said first plurality of stimulation parameters and saidsecond plurality of stimulation parameters are further selected suchthat, after at least one stimulation, an excess body weight of theperson reduces by at least 1% relative to an excess body weight of theperson before stimulation.

Optionally, said first plurality of stimulation parameters and secondplurality of stimulation parameters are further selected such that,after at least one stimulation, a total body weight of the personreduces by at least 1% relative to a total body weight of the personbefore stimulation and a well-being level of the person does not reducemore than 5% relative to a well-being level of the person beforestimulation.

Optionally, said first plurality of stimulation parameters and secondplurality of stimulation parameters are further selected such that,after at least one stimulation, an excess body weight of the personreduces by at least 1% relative to an excess body weight of the personbefore stimulation and a well-being level of the person does not reducemore than 5% relative to a well-being level of the person beforestimulation.

Optionally, said first plurality of stimulation parameters and secondplurality of stimulation parameters are further selected such that,after at least one stimulation, a pre-prandial ghrelin level of theperson reduces by at least 1% relative to a pre-prandial ghrelin levelof the person before stimulation.

Optionally, said first plurality of stimulation parameters and secondplurality of stimulation parameters are further selected such that,after at least one stimulation, a post-prandial ghrelin level of theperson reduces by at least 1% relative to a post-prandial ghrelin levelof the person before stimulation.

Optionally, said first plurality of stimulation parameters and secondplurality of stimulation parameters are further selected such that,after at least one stimulation session, exercise output of the patientincreases by at least 1% relative to the exercise output of the patientbefore stimulation.

Optionally, said first plurality of stimulation parameters and secondplurality of stimulation parameters are further selected such that,after at least one stimulation, a glucagon-like peptide-1 level of theperson increases by at least 1% relative to a glucagon-like peptide-1level of the person before stimulation.

Optionally, said first plurality of stimulation parameters and secondplurality of stimulation parameters are further selected such that,after at least one stimulation, a leptin level of the person increasesby at least 1% relative to a leptin level of the person beforestimulation.

Optionally, said first plurality of stimulation parameters and secondplurality of stimulation parameters are further selected such that,after at least one stimulation, the patient's appetite decreases, over apredefined period of time, relative to the patient's appetite beforestimulation and a nausea level of the patient does not increase by morethan 10%, over said predefined period of time, relative to the nausealevel of the patient before stimulation.

Optionally, said first plurality of stimulation parameters and secondplurality of stimulation parameters are further selected such that,after at least one stimulation, a peptide YY level of the personincreases by at least 1% relative to a peptide YY level of the personbefore stimulation.

Optionally, said first plurality of stimulation parameters and secondplurality of stimulation parameters are further selected such that,after at least one stimulation, a lipopolysaccharide level of the personreduces by at least 1% relative to a lipopolysaccharide level of theperson before stimulation.

Optionally, said first plurality of stimulation parameters and secondplurality of stimulation parameters are further selected such that,after at least one stimulation, a motilin-related peptide level of theperson reduces by at least 1% relative to a motilin-related peptidelevel of the person before stimulation.

Optionally, said first plurality of stimulation parameters and secondplurality of stimulation parameters are further selected such that,after at least one stimulation, a cholecystokinin level of the personincreases by at least 1% relative to a cholecystokinin level of theperson before stimulation.

Optionally, said first plurality of stimulation parameters and secondplurality of stimulation parameters are further selected such that,after at least one stimulation, a resting metabolic rate of the personincreases by at least 1% relative to a resting metabolic rate of theperson before stimulation.

Optionally, said first plurality of stimulation parameters and secondplurality of stimulation parameters are further selected such that,after at least one stimulation, a plasma-beta endorphin level of theperson increases by at least 1% relative to a plasma-beta endorphinlevel of the person before stimulation.

Optionally, said first plurality of stimulation parameters and secondplurality of stimulation parameters are further selected such that,after at least one stimulation, the patient's hunger decreases, over apredefined period of time, relative to the patient's hunger beforestimulation and a nausea level of the patient does not increase by morethan 10%, over said predefined period of time, relative to the nausealevel of the patient before stimulation.

Optionally, said first plurality of stimulation parameters and secondplurality of stimulation parameters are further selected such that,after at least one stimulation, the person's level of hemoglobin A1cdecreases by an amount equal to at least 0.3%.

Optionally, said first plurality of stimulation parameters and secondplurality of stimulation parameters are further selected such that,after at least one stimulation, a triglyceride level of the persondecreases by at least 1% relative to a triglyceride level of the personbefore stimulation.

Optionally, said first plurality of stimulation parameters and secondplurality of stimulation parameters are further selected such that,after at least one stimulation, a total blood cholesterol level of theperson decreases by at least 1% relative to a total blood cholesterollevel of the person before stimulation.

Optionally, said first plurality of stimulation parameters and secondplurality of stimulation parameters are further selected such that,after at least one stimulation, a glycemia level of the person decreasesby at least 1% relative to a glycemia level of the person beforestimulation.

Optionally, said first plurality of stimulation parameters and secondplurality of stimulation parameters are further selected such that,after at least one stimulation, a composition of the person's gutmicrobiota modulates from a first state to a second state, wherein thefirst state has a first level of bacteroidetes and a first level offirmicutes, wherein the second state has a second level of bacteroidetesand a second level of firmicutes, wherein the second level ofbacteroidetes is greater than the first level of bacteroidetes by atleast 3%, and wherein the second level of firmicutes is less than thefirst level of firmicutes by at least 3%.

In some embodiments, the present specification discloses a method ofenabling a person to comply with a diet plan comprising: providing anelectrical dermal patch adapted to adhere to the person's epidermallayer, wherein said electrical dermal patch comprises a controller, atleast one electrode adapted to be in electrical contact with saidpatient's epidermal layer, and a pulse generator in electricalcommunication with the controller and said at least one electrode;generating a plurality of electrical pulses having a treatment sessionduration and a treatment session frequency, wherein each of saidplurality of electrical pulses is defined by pulse width, a pulseamplitude, a pulse shape, a pulse frequency and wherein said pulseshape, pulse width, said pulse amplitude, and said pulse frequency areselected to enable the person to comply with the diet plan; using anapplication installed on an external device to acquire data over aperiod of time, said data including at least one of a timing of caloricconsumption, an amount of caloric consumption, a content of a caloricconsumption, an appetite level, a timing of appetite, a hunger level, asatiety level, a satiation level, a fullness level, an amount ofcalories burned, and an activity level; after said period of time,generating a signal, using said application, based upon said data;causing the signal to be transmitted to the electrical dermal patch;generating a second plurality of electrical pulses using a plurality ofstimulation parameters, said plurality of stimulation parameters beingdetermined based upon said signal and including at least one of a secondpulse width, a second pulse amplitude, a second pulse frequency, asecond pulse duty cycle, a second pulse shape, a second treatmentsession duration, and a second treatment session frequency; using saidapplication, causing at least a portion of at least one of said data andsaid plurality of stimulation parameters to be transmitted from saidexternal device to a server; using said server to store said at least aportion of said data and said plurality of stimulation parameters in adatabase; using said server to associate at least a portion of said dataand said plurality of stimulation parameters with an electronic profileof the patient; using said server to share said electronic profile ofthe patient with electronic profiles of other individuals; using saidserver to transmit to said application at least one of a timing ofcaloric consumption, an amount of caloric consumption, a content of acaloric consumption, an appetite level, a timing of appetite, a hungerlevel, a satiety level, a satiation level, a fullness level, an amountof calories burned, an activity level, and a plurality of stimulationparameters associated with one or more of said individuals; and visuallydisplaying in said application at least one of a timing of caloricconsumption, an amount of caloric consumption, a content of a caloricconsumption, an appetite level, a timing of appetite, a hunger level, asatiety level, a satiation level, a fullness level, an amount ofcalories burned, an activity level, and a plurality of stimulationparameters associated with one or more of said individuals inassociation with or relative to at least one of the timing of caloricconsumption, the amount of caloric consumption, the content of caloricconsumption, the appetite level, the timing of appetite, the hungerlevel, the satiety level, the satiation level, the fullness level, theamount of calories burned, the activity level, and the plurality ofstimulation parameters associated of the patient. It should beappreciated that server may refer to one or more computing devices,whether individually identifiable or collectively acting as a cloudservice.

Optionally, in any of the above embodiments, the duty cycle may bebetween 1% and 100% and the pulse shape of any one of monophasic,biphasic, and sinusoidal. Additionally, in any of the above embodiments,each of the stimulation sessions may be further defined as having astimulation session duration of 1 min to 120 min with 1 to 24stimulation sessions per day and 2 to 168 stimulation sessions per week.The stimulation session duration may also range from 1 min tosubstantially continuously.

Optionally, in any of the above embodiments, the stimulation sessionsare configured to provide alternating stimulation sessions between afirst session having a first pulse frequency equal to less than a pivotfrequency, such as 50 Hz or a frequency in a range of 25 to 75 Hz,followed by a second session having a second pulse frequency greaterthan the pivot frequency.

Optionally, said control device is further configured to monitor,record, and modify stimulation parameters of said stimulation protocol.The control device may comprise any one of a smartphone, tablet, andpersonal digital assistant and may be in data communication with aremote patient care facility or patient care personnel.

Optionally, said control device includes a graphical user interfacescreen configured to receive appetite, eating, weight, and activityinformation data from a patient and display said data on said screen.Still optionally, said control device is configured to generate anddisplay a plurality of charts and graphs representative of saidinformation data and, based upon said data, manage and generate promptsrelated to patient compliance on said graphical user interface screen.

Optionally, said control device is adapted to receive and integrateexercise and weight loss information from a third party device.

Optionally, said control device is configured to provide rescuestimulation sessions, wherein a rescue stimulation session is defined asan on-demand stimulation session applied at the onset of unplannedhunger events or potential occurrences of hunger events as determined byanalyzing said data.

Optionally, said stimulation device includes at least one sensor andsaid control device is configured to modify said stimulation parametersbased on data received from said at least one sensor. The sensor mayinclude any one or combination of a glucose sensor, a neural sensor, anaccelerometer, an impedance sensor, and a bio-impedance sensor.

The present specification also discloses a device for providingelectrical stimulation from the external surface of the patient'sepidermal layer through 5 mm, 10 mm, 15 mm, 20 mm, 25 mm or anyincrement therein of the dermis comprising: a housing comprising amicroprocessor, a wireless transceiver, a pulse generator, a powermanagement module, and at least one electrode extending from within thehousing or an external surface of the housing; at least one conductivepad configured to be in electrical communication with the electrode andbe placed on a skin surface of a patient, wherein said at least oneelectrode is positioned such that an electrical field generated by saidat least one electrode is shallow and widely distributed over said skinsurface, wherein shallow is defined as a depth of no more than 25 mmfrom said skin surface and widely distributed is defined as at least anarea of attachment of said at least one conductive pad to said skinsurface, further wherein said device provides a maximum output voltageof 500 V and a maximum output current of 500 mA.

The pad may have a shape including any one of irregular, rectangular,circular, square, elliptical, and triangular and wherein, at itslongest, a length of the pad ranges from 2 to 4 inches, at its widest, awidth or diameter of said pad ranges from 1.25 to 3 inches, and athickness of approximately 0.2 inches. In another embodiment, theelectrode/pad combination may have a shape including any one ofirregular, rectangular, circular, square, elliptical, and triangular andwherein, at its widest, would between 0.25 to 5 inches in width, at itstallest would be between 0.25 to 5 inches in height, and at its thickestwould be between 0.25 to 5 inches in thickness. In another embodiment,the device would comprise two of such electrode/pad combinations placedside by side.

The present specification also discloses a device for treating acondition, including at least one of obesity, over-weight, eatingdisorders, metabolic syndrome and diabetes in a patient, wherein saiddevice is configured to deliver electrical stimulation from the externalsurface of the patient's epidermal layer through a range of 0.1 mm to 25mm, or any increment therein, of the dermis by applying electricalstimulation to any one of an epidermis of a T2 frontal thoracicdermatome, an epidermis of a T3 frontal thoracic dermatome, an epidermisof a T4 frontal thoracic dermatome, an epidermis of a T5 frontalthoracic dermatome, an epidermis of a T6 frontal thoracic dermatome, anepidermis of a T7 frontal thoracic dermatome, an epidermis of a T8frontal thoracic dermatome, an epidermis of a T9 frontal thoracicdermatome, an epidermis of a T10 frontal thoracic dermatome, anepidermis of a T11 frontal thoracic dermatome, and an epidermis of a T12frontal thoracic dermatome of said patient, further wherein electricalstimulation is increased based on data from a first parameter andelectrical stimulation is decreased based on data from a secondparameter. The first parameter may include any one of appetite, hunger,weight, body mass index (BMI), and body fat and said second parametermay include any one of nausea, dyspepsia, heartburn, and sensation atthe site of stimulation.

The present specification also discloses a device for treating acondition, including at least one of obesity, over-weight, eatingdisorders, metabolic syndrome and diabetes in a patient, wherein saiddevice is configured to deliver electrical stimulation from the externalsurface of the patient's epidermal layer through a range of 0.1 mm to 25mm, or any increment therein, of the dermis by applying electricalstimulation to any one of an epidermis of a T2 frontal thoracicdermatome, an epidermis of a T3 frontal thoracic dermatome, an epidermisof a T4 frontal thoracic dermatome, an epidermis of a T5 frontalthoracic dermatome, an epidermis of a T6 frontal thoracic dermatome, anepidermis of a T7 frontal thoracic dermatome, an epidermis of a T8frontal thoracic dermatome, an epidermis of a T9 frontal thoracicdermatome, an epidermis of a T10 frontal thoracic dermatome, anepidermis of a T11 frontal thoracic dermatome, and an epidermis of a T12frontal thoracic dermatome of said patient, further wherein electricalstimulation is decreased based on data indicative of excessive appetiteloss, excessive hunger loss, an actual weight less than a target weight,an actual caloric intake less than a target caloric intake, an actualBMI less than a target BMI.

The present specification also discloses a device for treating acondition, including at least one of obesity, over-weight, eatingdisorders, metabolic syndrome and diabetes in a patient, wherein saiddevice is configured to deliver electrical stimulation from the externalsurface of the patient's epidermal layer through a range of 0.1 mm to 10mm or a range of 0.1 mm to 20 mm of the dermis by applying electricalstimulation to any one of an epidermis of a T2 frontal thoracicdermatome, an epidermis of a T3 frontal thoracic dermatome, an epidermisof a T4 frontal thoracic dermatome, an epidermis of a T5 frontalthoracic dermatome, an epidermis of a T6 frontal thoracic dermatome, anepidermis of a T7 frontal thoracic dermatome, an epidermis of a T8frontal thoracic dermatome, an epidermis of a T9 frontal thoracicdermatome, an epidermis of a T10 frontal thoracic dermatome, anepidermis of a T11 frontal thoracic dermatome, and an epidermis of a T12frontal thoracic dermatome of said patient, further wherein said patientis stimulated with a first stimulation algorithm to induce weight lossand a second stimulation algorithm to maintain weight loss, wherein afirst total stimulation energy per day of said first stimulationalgorithm is greater than a second total stimulation energy per day ofsaid second stimulation algorithm.

The present specification also discloses a device for suppressingappetite or food cravings in a patient, said device comprising: a devicebody having a length no greater than 5 inches, a width no greater than 2inches, and a height no greater than 1.5 inches, preferably no greaterthan 0.35 inches, and comprising a microprocessor, a wirelesstransceiver, a pulse generator, a power management module, and at leastone electrode extending along a bottom surface of said device body; andwherein said device is configured to deliver electrical stimulation fromthe external surface of the patient's epidermal layer through a range of0.1 mm to 10 mm or a range of 0.1 mm to 20 mm of the dermis by applyingelectrical stimulation to any one of an epidermis of a T2 frontalthoracic dermatome, an epidermis of a T3 frontal thoracic dermatome, anepidermis of a T4 frontal thoracic dermatome, an epidermis of a T5frontal thoracic dermatome, an epidermis of a T6 frontal thoracicdermatome, an epidermis of a T7 frontal thoracic dermatome, an epidermisof a T8 frontal thoracic dermatome, an epidermis of a T9 frontalthoracic dermatome, an epidermis of a T10 frontal thoracic dermatome, anepidermis of a T11 frontal thoracic dermatome, and an epidermis of a T12frontal thoracic dermatome of said patient; and wherein said device isprogrammed with a stimulation protocol for providing electricalstimulation to said patient, wherein said stimulation protocol isconfigured to provide stimulation non-continuously and for at least twostimulation sessions per week, wherein each of said stimulation sessionshas an on period of 10 to 120 minutes or substantially continuously.

In some embodiments, the present specification is directed toward amethod of modulating a patient's glucose level, the method comprising:providing an electrical dermal patch adapted to adhere to the patient'sepidermal layer, wherein said electrical dermal patch comprises acontroller, at least one electrode adapted to be in electrical contactwith said patient's epidermal layer, and a pulse generator in electricalcommunication with the controller and said at least one electrode;defining a plurality of stimulation parameters; providing a glucosesensor to the patient for continuously monitoring said patient's glucoselevel in a closed loop configuration; and programming the pulsegenerator to generate a plurality of electrical pulses using saidplurality of stimulation parameters, and stimulating said patient basedon a threshold glucose level, wherein after applying at least onestimulation to the patient's epidermal layer, the patient's glucoselevel is modified, and wherein said modification may result in amodification of said stimulation.

Optionally, stimulation is stopped once a predefined lower glucose levelis achieved.

Optionally, an optimal or intense stimulation protocol is initiated ifthe patient's glucose level is higher than a predetermined thresholdlevel.

Optionally, after at least one stimulation session, the level ofhemoglobin A1C decreases by at least 1% with a p value of 0.05.

Optionally, after at least one stimulation session, the level ofhemoglobin A1C is completely normalized.

Optionally, after at least one stimulation session, the level ofhemoglobin A1C is ≤7.0%.

In some embodiments, the present specification discloses a method ofmodulating a patient's will power reserve, the method comprising:providing an electrical dermal patch adapted to adhere to the patient'sepidermal layer, wherein said electrical dermal patch comprises acontroller, at least one electrode adapted to be in electrical contactwith said patient's epidermal layer, and a pulse generator in electricalcommunication with the controller and said at least one electrode;defining a plurality of stimulation parameters; and programming thepulse generator to generate a plurality of electrical pulses using saidplurality of stimulation parameters, wherein said plurality ofstimulation parameters are defined such that, after applying at leastone stimulation to the patient's epidermal layer, the patient's willpower reserve is modified, and wherein said will power reserve is afunction of any one or a combination of at least the patient's hungerscore, dietary compliance, level of exercise, appetite control, amountof calories consumed, type of calories consumed, timing of meals, andweight. Optionally, said will power reserve is an inverse function ofhunger score.

Optionally, said will power reserve is a composite function of dietarywill power and exercise will power, wherein said dietary will power iseither an inverse function of hunger score or a directly proportionalfunction of dietary compliance, and wherein said exercise will power isa directly proportional function of level of exercise.

Optionally, said dietary will power is a directly proportional compositefunction of dietary compliance and appetite control, and wherein saiddietary compliance is a function of at least the amount of caloriesconsumed and the type of calories consumed.

Optionally, one or both of the following occurs if the patient'sappetite control and dietary compliance are low: a dietary will powergraph is displayed to be in red zone, the electro dermal patch flashesred color using at least one LED.

Optionally, one or both of the following occurs if the patient'sappetite control and dietary compliance increases: a dietary will powergraph is displayed to be in yellow zone, the electro dermal patchflashes yellow color using at least one LED.

Optionally, one or both of the following occurs if the patient'sappetite control and dietary compliance are high: a dietary will powergraph is displayed to be in green zone, the electro dermal patch flashesgreen color using at least one LED.

Optionally, said will power reserve is an inverse function of an urge toeat profile of the patient, and wherein said urge to eat profile is afunction of at least one of amount of calories consumed, type ofcalories consumed, timing of meals.

Optionally, said will power reserve is a composite function of at leasttwo of amount of calories consumed, type of calories consumed, timing ofmeals, level of exercise, weight.

Optionally, said will power reserve is a composite function of hungerscore improvement, dietary compliance and level of exercise.

Optionally, the patient is periodically presented with VAS light bars torecord the patient's inputs related to success in maintaining a dietplan, success in limiting out-of-meal plan snacking, success in eatinghealthy foods, and success in controlling hunger.

Optionally, said will power reserve also includes at least one of bonuspoints earned for each hunger rescue bolus, bonus points earned forexercising, bonus points earned for filling out the patient's dailydiary, bonus points earned for favorable daily weight change, bonuspoints earned for positive coaching of other patients within thepatient's social network group.

Optionally, the patient provides input on a displayed light bar VAS toassess dietary will power on a periodic basis.

Optionally, the patient's will power reserve is displayed in the form ofa graph.

Optionally, the patient is a member of an affinity group comprising aplurality of members, each of said members having an associated willpower reserve profile generated from archived daily will power reserveof each member over a period of time. Optionally, a collective willpower reserve of said affinity group is determined based on will powerreserve of each member of the affinity group. Optionally, the collectivewill power reserve is an average of the will power reserve of eachmember of the affinity group.

Optionally, a member with at least a predefined minimum will powerreserve is allowed to coach other members.

Optionally, a member's will power reserve above a predefined thresholdresults in at least one reward for the member.

Optionally, a member is allowed to subscribe to dietary plans, exerciseregimes, and/or stimulation parameters of other members who haveattained a predefined threshold will power reserve.

Optionally, a member's will power reserve enables the member toaccumulate points and bonuses corresponding to a degree of will powerreserve, and use said points and bonuses to earn a plurality of rewardsand participate in games among members of the affinity group.

In some embodiments, the present specification discloses a method ofstimulating a patient's somatovisceral reflex system comprising:providing an electrical dermal patch adapted to adhere to the patient'sepidermal layer, wherein said electrical dermal patch comprises acontroller, at least one electrode adapted to be in electrical contactwith said patient's epidermal layer, and a pulse generator in electricalcommunication with the controller and said at least one electrode;defining a plurality of stimulation parameters; and programming thepulse generator to generate a plurality of electrical pulses using saidplurality of stimulation parameters, wherein said plurality ofstimulation parameters are defined such that, after applying at leastone stimulation to the patient's epidermal layer, at least one of thepatient's antral motility, gastric emptying, appetite, weight, ghrelin,insulin, and glycemia is modified.

Optionally, the stimulation of the patient's somatovisceral reflexsystem involves delivering said plurality of electrical pulses to atleast one of the following dermatomes: T2-T12, C5-T1.

Optionally, the stimulation of the somatovisceral reflex system isenhanced by coinciding stimulation sessions with pre-prandial and/orpost-prandial windows.

Optionally, said pre-prandial window relates to a first period involvingsecretion of ghrelin just prior to anticipated eating, and wherein saidpost-prandial window relates to a second period involving digestiveactivity after a meal.

Optionally, said first period spans approximately 60 minutes prior toanticipated eating, and wherein said second period spans approximately 2hours after a meal.

Optionally, said first period spans approximately 60 minutes prior toanticipated eating, and wherein said second period spans approximately60 minutes after a meal.

In some embodiments, the present specification discloses a method ofmodulating at least one of a person's appetite, hunger, satiety level,or satiation comprising: providing an electrical dermal patch adapted toadhere to the person's epidermal layer, wherein said electrical dermalpatch comprises a controller, at least one electrode adapted to be inelectrical contact with said person's epidermal layer, and a pulsegenerator in electrical communication with the controller and said atleast one electrode; defining a first plurality of stimulationparameters, wherein said first plurality of stimulation parameterscomprises a treatment session duration, a stimulation amplitude, andfrequency of treatment sessions; generating a plurality of electricalpulses using said first plurality of stimulation parameters, whereinsaid first plurality of stimulation parameters are defined such that,after applying at least one stimulation to the patient's epidermallayer, at least one of the patient's appetite, hunger, satiety level,and satiation level is modified; using an application installed on adevice separate from the electrical dermal patch to acquire data, saiddata being indicative of at least one of the person's appetite, hunger,satiety level, satiation level, fullness level, amount of caloricintake, weight, type of caloric intake, and timing of caloric intake;generating a signal, using said application, based upon said data; andcausing the signal to be transmitted to the electrical dermal patch.

Optionally, the treatment session duration is in a range of 20 to 40minutes.

Optionally, the stimulation amplitude is in a range of 10 mA to 30 mA.

Optionally, the frequency of treatment sessions is three times per day.

Optionally, the frequency of treatment sessions is configured toinitiate in a range of 20 minutes to 90 minutes before the person'smealtimes.

Optionally, the application is configured to generate a graphical userinterface comprising a visual bar and configured to receive, from theperson, an input modifying a position of the visual bar based on ahunger level of the person and wherein, upon modifying the position ofthe visual bar, the application is configured to modify one or more ofsaid first plurality of stimulation parameters.

Optionally, the device separate from the electrical dermal patch is atleast one of a mobile phone, tablet computer, intelligent personalassistant, chat robot, chatter robot, chatterbot, chat bot, artificialconversational entities, artificial intelligence agent, talk bot, andchatterbox.

In some embodiments, the present specification discloses a method forenabling a TPM to prescribe, configure, manage, monitor and intervene anEDP device based stimulation therapy for a user.

Optionally, a user visits his TPM for a medical check-up or evaluation.Optionally, the TPM recommends an EDP device of the presentspecification to the user based on the user's medical condition, such asfor example obesity or over-weight.

Optionally, the TPM downloads the HMA on the user's smartphone (thatworks as a companion device).

Optionally, the TPM assists the user in identifying appropriate areas ofstimulation (and therefore, placement of the EDP device on the user'sbody), such as T6, C8 and/or T1 dermatomes for conditions of obesity,over-weight, eating disorders, metabolic syndrome and T7 for T2DMmanagement, and also provides an orientation to the user regarding useand functions of the electro-dermal patch device. The EDP device ispositioned on the identified location on the user's body.

Optionally, the TPM associates or links himself to the user, the user'sEDP device and HMA, such as, by inputting his unique code into theuser's HMA. Still optionally, the TPM pairs or syncs the user'ssmartphone with the user's EDP device.

Optionally, the TPM configures or programs the stimulation protocols andparameters, including various associated thresholds, ranges, related toplanned therapy sessions as well as unplanned on-demand rescue sessions.The TPM may, optionally, also prescribe a low calorie planned diet forthe user. Optionally, the HMA acknowledges that the configuration (bythe TPM) is successful and the EDP device also optionally acknowledgessuccessful configuration by, for example, vibratory, auditory and/orvisual indications or signals (such as flashing LEDs of a specificcolor).

Optionally, the TPM delivers a first planned therapy session to the userin the presence of the TPM to ensure that the HMA or therapyconfiguration is conducive to the user.

Optionally, if the user feels fine after the first session, the user isallowed to leave to continue the therapy at home or if the user reportsinconvenience or deterioration in well-being, such as due to a feelingof nausea, the TPM reprograms the stimulation protocols and parameters.

Optionally, at home, the user continues with the stimulation therapy andgenerates a plurality of health related information (such as, but notlimited to, the user's weight, scores related to appetite, hunger,exercise, well-being (well-being profile including recorded nauseaand/or dyspepsia events), values related to calories consumed, andindividualized hunger profile (as a result of recorded unplanned hungerevents and delivered rescue sessions) during therapy.

Optionally, if and when needed, the TPM modulates the stimulationparameters and protocols, for both planned as well as rescue sessions,based on the plurality of user's health related information while theuser is continuing with the stimulation therapy at home. Optionally, theTPM also intervenes, by re-setting or reprogramming the EDP device andHMA and/or deactivating and reactivating the EDP device, when needed.Optionally, the user's stimulation is stopped, paused and/or the userprompted to revisit his TPM for re-evaluation of his medical conditionor progress.

Optionally, a user has a plurality of options for purchasing the EDPdevice along with the TPM's services. Optionally, the TPM's fee scheduleis enforced through his unique code that is valid only for thepredefined period of time. Optionally, the TPM's fee is linked to theuser achieving one or more therapeutic goals within a period of time.

The aforementioned and other embodiments of the present specificationshall be described in greater depth in the drawings and detaileddescription provided below.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features and advantages of the present specificationwill be further appreciated, as they become better understood byreference to the following detailed description when considered inconnection with the accompanying drawings:

FIG. 1A is a block diagram of a system for stimulating nerves and nerveendings in body tissue, in accordance with various embodiments of thepresent specification;

FIG. 1B is a block diagram of a system for stimulating or modulatingnerves and nerve endings in body tissues, in accordance with anotherembodiment of the present specification;

FIG. 1C is a block diagram of a system for stimulating or modulatingnerves and nerve endings in body tissues, in accordance with yet anotherembodiment of the present specification;

FIG. 1D is a block diagram of a system for stimulating or modulatingnerves and nerve endings in body tissues, in accordance with yet anotherembodiment of the present specification;

FIG. 1E is a block diagram of a system for stimulating or modulatingnerves and nerve endings in body tissues, in accordance with stillanother embodiment of the present specification;

FIG. 1F is a block diagram of a system for stimulating or modulatingnerves and nerve endings in body tissues, in accordance with yet anotherembodiment of the present specification;

FIG. 2A is a side perspective view of an electro-dermal patch (EDP)device, in accordance with some embodiments of the presentspecification;

FIG. 2B is a front perspective view of the electro-dermal patch deviceof FIG. 2A;

FIG. 2C is a top perspective view of the electro-dermal patch device ofFIG. 2A;

FIG. 2D is an oblique perspective view of an electro-dermal patch withhydrogel removed and a replacement hydrogel with liners, in accordancewith one embodiment of the present specification;

FIG. 3A illustrates a first pattern of electrodes, in accordance withcertain embodiments;

FIG. 3B illustrates a second pattern of electrodes, in accordance withcertain embodiments;

FIG. 4A is a perspective view of an electro-dermal patch deviceconfigured to provide electrical stimulation therapy, in accordance withsome embodiments;

FIG. 4B is a side perspective view of an electro-dermal patch device, inaccordance with another embodiment of the present specification;

FIG. 4C is a bottom perspective view of the electro-dermal patch deviceof FIG. 4B;

FIG. 4D is an oblique, top perspective view of an electro-dermal patchdevice, in accordance with another embodiment of the presentspecification;

FIG. 4E is an oblique, top perspective view of the controller assemblyof the electro-dermal patch device of FIG. 4D;

FIG. 4F is an oblique, bottom perspective view of the controllerassembly of the electro-dermal patch device of FIG. 4D;

FIG. 4G is a side perspective cross-sectional view of an electro-dermalpatch device comprising a capacitance type connection (dielectricmaterial) between the electrode contacts and a hydrogel of the electrodeassembly, in accordance with one embodiment of the presentspecification;

FIG. 4H is an oblique, top perspective view of the controller assemblyof the electro-dermal patch device of FIG. 4D with a portion of theovermold cut away to expose additional components of the controllerassembly;

FIG. 4I is an oblique, top perspective view of the electrode assembly ofthe electro-dermal patch device of FIG. 4D;

FIG. 4J is an oblique, bottom perspective view of the electro-dermalpatch device of FIG. 4D;

FIG. 4K is a side perspective view of the electro-dermal patch device ofFIG. 4D;

FIG. 4L is an oblique, top perspective, short axis cross-sectional viewof the electro-dermal patch device of FIG. 4D;

FIG. 4M is a front perspective cross-sectional view of theelectro-dermal patch device of FIG. 4D;

FIG. 4N is an oblique, top perspective, long axis cross-sectional viewof the electro-dermal patch device of FIG. 4D;

FIG. 4O is a side perspective cross-sectional view of the electro-dermalpatch device of FIG. 4D;

FIG. 4P illustrates a first pattern of electrodes of the electro-dermalpatch device of FIG. 4D, in accordance with an embodiment;

FIG. 4Q illustrates a second pattern of electrodes of the electro-dermalpatch device of FIG. 4D, in accordance with an embodiment;

FIG. 4R illustrates a third pattern of electrodes of the electro-dermalpatch device of FIG. 4D, in accordance with an embodiment;

FIG. 4S illustrates a fourth pattern of electrodes of the electro-dermalpatch device of FIG. 4D, in accordance with an embodiment;

FIG. 5A is an oblique, top perspective view of an electro-dermal patchdevice in accordance with some embodiments;

FIG. 5B is a side perspective view of the EDP device of FIG. 5A;

FIG. 5C is a bottom view of the EDP device of FIG. 5A;

FIG. 5D is an oblique, top perspective view of the EDP device of FIG. 5Awith a portion of an overmold removed;

FIG. 5E is a side cross-sectional view of the EDP device of FIG. 5D;

FIG. 5F is a top perspective view of the EDP device of FIG. 5A with theentire overmold removed;

FIG. 6A illustrates an electro-dermal patch device of the presentspecification, configured as a skin patch, placed at a lateral thoracicdermatome and being wirelessly controlled by a smartphone, in accordancewith various embodiments;

FIG. 6B is a schematic diagram of a plurality of electro-dermal patchusers with companion devices shared over a common network connection, inaccordance with one embodiment of the present specification;

FIG. 6C is a flow chart listing the steps in one embodiment of a methodof aggregating, organizing, and analyzing stimulation parameters andpatient hunger, appetite, and well-being scores for a plurality ofpatients, each having an EDP device with linked companion deviceconnected to an aggregate patient network;

FIG. 6D is a flow chart illustrating the steps involved in using one ormore downloadable applications to configure and reconfigure stimulationprovided by an electro-dermal patch (EDP) device, in accordance with oneembodiment of the present specification;

FIG. 6E is a flow chart illustrating the steps involved in a method of acompanion device verifying and/or authenticating data transmissionreceived from a remote server, in accordance with some embodiments ofthe present specification;

FIG. 6F is a flow chart illustrating the steps involved in a method ofencrypting, authenticating, and/or verifying data transmissions betweenan EDP, companion device, and remote server based on FDA approval statusof the EDP, in accordance with some embodiments of the presentspecification;

FIG. 7 is a screen shot of a companion device depicting a diary widget,in accordance with one embodiment of the present specification;

FIG. 8 is a screen shot of a companion device depicting a list view ofdiary entries, in accordance with one embodiment of the presentspecification;

FIG. 9 is a screen shot of a companion device depicting a calendar viewof diary entries, in accordance with one embodiment of the presentspecification;

FIG. 10 is a screen shot of a companion device depicting a quick entrybuttons view, in accordance with one embodiment of the presentspecification;

FIG. 11 is a screen shot of a companion device depicting an appetiteentry screen, in accordance with one embodiment of the presentspecification;

FIG. 12 is a screen shot of a companion device depicting an exerciseentry screen, in accordance with one embodiment of the presentspecification;

FIG. 13 is a screen shot of a companion device depicting a hunger entryscreen, in accordance with one embodiment of the present specification;

FIG. 14 is a screen shot of a companion device depicting a stimulationsession entry screen, in accordance with one embodiment of the presentspecification;

FIG. 15 is a screen shot of a companion device depicting a weight entryscreen, in accordance with one embodiment of the present specification;

FIG. 16 is a screen shot of a companion device depicting a well-beingentry screen, in accordance with one embodiment of the presentspecification;

FIG. 17A is an illustration depicting the distribution of the front andlateral T2-T12 dermatomes across a thorax and abdomen of a human body;

FIG. 17B is an illustration depicting the distribution of the anteriorand posterior C5-T1 dermatomes across a hand, arm and upper chestregions of a human body;

FIG. 17C is an illustration depicting the distribution of the C5-T1dermatomes across the ventral side of the hand and lower arm of thehuman body;

FIG. 17D is a flow chart listing the steps involved in one method ofidentifying a proper placement location for an electro-dermal patch on afront thoracic surface of a patient, in accordance with one embodimentof the present specification;

FIG. 17E is an illustration depicting region on a front and back side ofthe hand of the human body innervated by a median nerve;

FIG. 18A illustrates T6 stimulation using an electro-dermal patchdevice, in accordance with certain embodiments;

FIG. 18B illustrates T7 stimulation using an electro-dermal patchdevice, in accordance with certain embodiments;

FIG. 18C illustrates T6 and T7 stimulation using an electro-dermal patchdevice, in accordance with certain embodiments;

FIG. 19A illustrates C8 stimulation position of the ventral or front(palm) side of a user's hand using an electro-dermal patch, inaccordance with certain embodiments;

FIG. 19B illustrates C8 stimulation position of the dorsal or back sideof the user's hand using an electro-dermal patch, in accordance withcertain embodiments;

FIG. 19C illustrates C8 and T1 stimulation position of the ventral sideof the user's lower arm or wrist regions using an electro-dermal patch,in accordance with certain embodiments;

FIG. 19D illustrates median nerve stimulation position of the ventraland dorsal side of the user's lower arm or wrist regions using anelectro-dermal patch, in accordance with certain embodiments;

FIG. 20A illustrates an embodiment of an electro-dermal patch device ofthe present specification wrapped around the edge of the user's hand forstimulating the C8 dermatome;

FIG. 20B illustrates another embodiment of an electro-dermal patchdevice of the present specification wrapped around the edge of theuser's hand for stimulating the C8 dermatome;

FIG. 21A is a perspective view of a band incorporating an EDP(electro-dermal patch) device of the present specification, inaccordance with an embodiment;

FIG. 21B is a perspective view of a wristwatch incorporating an EDPdevice of the present specification, in accordance with an embodiment;

FIG. 22A illustrates a first embodiment of a hand glove incorporatingone or more EDP devices of the present specification;

FIG. 22B illustrates a second embodiment of a pair of hand glovesincorporating one or more EDP devices of the present specification;

FIG. 22C illustrates a third embodiment of a pair of hand glovesincorporating one or more EDP devices of the present specification;

FIG. 22D illustrates a fourth embodiment of a hand glove incorporatingat least one EDP device of the present specification;

FIG. 23 is a perspective view of hand gear incorporating at least oneEDP device of the present specification, in accordance with anembodiment;

FIG. 24 is a perspective view of a finger ring incorporating an EDPdevice of the present specification, in accordance with an embodiment;

FIG. 25 illustrates a squeezable ball incorporating an EDP device of thepresent specification, in accordance with an embodiment;

FIG. 26 illustrates hand gear incorporating an EDP device of the presentspecification, in accordance with an embodiment;

FIG. 27A is a flow chart illustrating the steps involved in a method ofdetermining stimulation reaction thresholds and using an electro-dermalpatch (EDP) device to suppress appetite in a patient, in variousembodiments of the present specification;

FIG. 27B is a flow chart illustrating the steps involved in a method ofdetermining stimulation reaction thresholds and using an electro-dermalpatch (EDP) device to suppress appetite in a patient, in variousembodiments of the present specification;

FIG. 27C is a flow chart illustrating the steps involved in a method ofusing an electro-dermal patch device to suppress appetite in a patient,in various embodiments of the present specification;

FIG. 28 is a flow chart illustrating the steps involved in a method ofusing an electro-dermal patch device to suppress appetite in a patient,in various embodiments of the present specification;

FIG. 29 is a flow chart illustrating the steps involved in a method ofusing an electro-dermal patch device to suppress appetite in a patient,in various embodiments of the present specification;

FIG. 30 is a flow chart illustrating the steps involved in a method ofusing an electro-dermal patch device to suppress appetite in a patient,in various embodiments of the present specification;

FIG. 31 is a flow chart illustrating the steps involved in a method ofusing an electro-dermal patch device to suppress appetite in a patient,in various embodiments of the present specification;

FIG. 32 is a flow chart illustrating the steps involved in methods ofusing an electro-dermal patch device to suppress appetite in a patient,in various embodiments of the present specification;

FIG. 33 is a flow chart illustrating the steps involved in a using anelectro-dermal patch device and a companion device, paired with aseparate monitoring device, to suppress appetite in a patient, inaccordance with an embodiment of the present specification;

FIG. 34 is a flow chart illustrating steps involved in methods of usingan electro-dermal patch device to suppress appetite in a patient, invarious embodiments of the present specification;

FIG. 35A is a Visual Analogue Scale (VAS) questionnaire for assessing afeeling of hunger or appetite, in accordance with an embodiment;

FIG. 35B is a VAS questionnaire for assessing a feeling of fullness, inaccordance with an embodiment;

FIG. 35C is a VAS questionnaire for assessing a feeling of satiation, inaccordance with an embodiment;

FIG. 35D is a VAS questionnaire for assessing a feeling of satiety, inaccordance with an embodiment;

FIG. 36A is a graph illustrating pre-stimulation and post-stimulationhunger profiles of a first patient, in accordance with an embodiment;

FIG. 36B is a graph illustrating pre-stimulation and post-stimulationhunger profiles of a second patient, in accordance with an embodiment;

FIG. 36C is a graph illustrating pre-stimulation and post-stimulationhunger profiles of a third patient, in accordance with an embodiment;

FIG. 36D is a graph illustrating pre-stimulation and post-stimulationhunger profiles of a fourth patient, in accordance with an embodiment;

FIG. 36E is a graph illustrating pre-stimulation and post-stimulationhunger profiles of a fifth patient, in accordance with an embodiment;

FIG. 36F is a graph illustrating median AUC (Area Under the Curve)hunger scores for pre-stimulation, end-of-stimulation andpost-stimulation scenarios;

FIG. 36G is a graph illustrating pre-stimulation and post-stimulationhunger profiles over an extended period of time, in accordance with afirst embodiment;

FIG. 36H is a graph illustrating pre-stimulation and post-stimulationhunger profiles over an extended period of time, in accordance with asecond embodiment;

FIG. 36I is a graph illustrating hunger scores for pre-stimulation,end-of-stimulation and post-stimulation scenarios;

FIG. 37A is a graph illustrating pre-stimulation and post-stimulationsatiety profiles of a first patient, in accordance with an embodiment;

FIG. 37B is a graph illustrating pre-stimulation and post-stimulationsatiety profiles of a second patient, in accordance with an embodiment;

FIG. 37C is a graph illustrating pre-stimulation and post-stimulationsatiety profiles of a third patient, in accordance with an embodiment;

FIG. 37D is a graph illustrating pre-stimulation and post-stimulationsatiety profiles of a fourth patient, in accordance with an embodiment;

FIG. 37E is a graph illustrating pre-stimulation and post-stimulationsatiety profiles of a fifth patient, in accordance with an embodiment;

FIG. 37F is a graph illustrating median AUC (Area Under the Curve)satiety scores for pre-stimulation, end-of-stimulation andpost-stimulation scenarios;

FIG. 37G is a graph illustrating pre-stimulation and post-stimulationsatiety profiles over an extended period of time, in accordance with afirst embodiment;

FIG. 37H is a graph illustrating pre-stimulation and post-stimulationsatiety profiles over an extended period of time, in accordance with asecond embodiment;

FIG. 37I is a graph illustrating satiety scores for pre-stimulation,end-of-stimulation and post-stimulation scenarios;

FIG. 38A is a graph illustrating exercise scores of a sample of patientstreated with stimulation therapy, in accordance with an embodiment ofthe present specification;

FIG. 38B is a graph illustrating weights of a sample of patients treatedwith stimulation therapy, in accordance with an embodiment of thepresent specification;

FIG. 38C is a graph illustrating BMIs (Body Mass Index) of a sample ofpatients treated with stimulation therapy, in accordance with anembodiment of the present specification;

FIG. 38D is a graph illustrating appetite scores of a sample of patientstreated with stimulation therapy, in accordance with an embodiment ofthe present specification;

FIG. 38E is a graph illustrating dietary compliance scores of a sampleof patients treated with stimulation therapy, in accordance with anembodiment of the present specification;

FIG. 38F is a graph illustrating well-being scores of a sample ofpatients treated with stimulation therapy, in accordance with anembodiment of the present specification;

FIG. 39 is a side view illustration of an EDP device, in accordance witha less preferred embodiment;

FIG. 40 is a side view illustration of another EDP device, in accordancewith a less preferred embodiment;

FIG. 41 is a side view illustration of still another EDP device, inaccordance with a less preferred embodiment;

FIG. 42 is a side view illustration of yet another EDP device, inaccordance with a less preferred embodiment;

FIG. 43 is an illustration of a percutaneous multi-electrode array thatmay be employed with the devices of the present specification;

FIG. 44 is a block diagram of a mobile electronics platform that may beemployed with the devices of the present specification;

FIG. 45 is an illustration of an EDP device that receives wirelessenergy for stimulation, in accordance with a less preferred embodiment;

FIG. 46 is an illustration of another EDP device that receives wirelessenergy for stimulation, in accordance with a less preferred embodiment;

FIG. 47A is a bar graph illustrating mean cumulative changes of antralmotility indices for various stimulation sessions, in accordance with anembodiment;

FIG. 47B is a bar graph illustrating maximum plasma endorphin levelsmeasured for various stimulation sessions, in accordance with anembodiment;

FIG. 48A is a block diagram illustration of a Health ManagementApplication (HMA) in communication with an Intelligent PersonalAssistant (IPA) system, in accordance with embodiment;

FIG. 48B is a block diagram illustration of the HMA in communicationwith the IPA system, in accordance with another embodiment;

FIG. 48C is a block diagram illustration of the HMA, of the presentspecification, in communication with the IPA system as well as a BigData database server, in accordance with an exemplary embodiment;

FIG. 49 is a flow chart illustrating exemplary steps involved in oneembodiment of a method of using an electro-dermal patch device toautomatically drive rescue therapy based on the user's individualizedhunger profile or map;

FIG. 50 is a flow chart illustrating exemplary steps involved in oneembodiment of a method of using an electro-dermal patch device toautomatically titrate therapy based on the user's dynamic well-beingprofile;

FIG. 51 is a depiction of a graphical user interface with a visual lightbar;

FIG. 52 is a flow chart illustrating a method for enabling a TPM toprescribe, configure, manage, monitor and intervene with an EDPdevice-based stimulation therapy for a user, in accordance with someembodiments;

FIG. 53A is a horizontal bar graph illustrating a will power levelcorresponding to low or decreased levels of hunger;

FIG. 53B is the bar graph of FIG. 53A illustrating a will power levelcorresponding to high levels of hunger;

FIG. 54A is a vertical bar graph illustrating dietary will power of auser;

FIG. 54B is a vertical bar graph illustrating exercise will power of theuser;

FIG. 55A is a top perspective view of an EDP device in accordance withan embodiment of the present specification;

FIG. 55B is another top perspective view of the EDP device in accordancewith an embodiment of the present specification;

FIG. 55C is a bottom perspective view of the EDP device of FIG. 55A;

FIG. 55D is a bottom perspective view of the EDP device of FIG. 39A withhydrogel pads removed;

FIG. 55E is a side perspective view of the EDP device of FIG. 55A;

FIG. 55F is a first side perspective view of the EDP device of FIG. 55Awith a portion of the housing cut away;

FIG. 55G is a second side perspective view of the EDP device of FIG. 55Awith a portion of the housing cut away;

FIG. 55H is a top perspective view of an EDP device in accordance withsome embodiments;

FIG. 55I is a top perspective view of another EDP device in accordancewith some embodiments;

FIG. 55J is a top perspective view of yet another EDP device inaccordance with some embodiments;

FIG. 55K shows a bottom view of a waterproof electrode pad assembly thatutilizes two types of skin contacting adhesives, in accordance with someembodiments;

FIG. 55L is a disassembled or exploded view of the electrode padassembly of FIG. 55K;

FIG. 55M is a disassembled or exploded view of electrode pad assemblyemploying either a foam pad with acrylic adhesive or a hydrocolloidadhesive;

FIG. 56 illustrates an exemplary use of a swallow detection device, inaccordance with some embodiments;

FIG. 57 is a flow chart illustrating the steps involved in oneembodiment of a method of using an electro-dermal patch device to elicitfeedback, related to a medical condition of a patient, from at least oneof a social network group (or affinity group) and an online coaching orconcierge service;

FIG. 58 is a flow chart of a plurality of exemplary steps of an eatingmoment recognition method, in accordance with some embodiments;

FIG. 59A illustrates a first pulse waveform, in accordance with anembodiment;

FIG. 59B illustrates a second pulse waveform, in accordance with anembodiment;

FIG. 60 shows a graph comparing the % Total Body Weight Loss (% TBWL)achieved using the EDP devices of the present specification for 3 monthsagainst the % TBWL achieved using an Intragastric Balloon for 6 months;

FIG. 61 illustrates a third pulse waveform, in accordance with anembodiment of the present specification;

FIG. 62 is a flowchart illustrating steps of example use cases oftitrating stimulation therapy based at least on a user's glucose statusdata, in accordance with embodiments of the present specification;

FIG. 63 is a flowchart illustrating steps of additional example usecases of titrating stimulation therapy based at least on a user'sglucose status data, in accordance with embodiments of the presentspecification;

FIG. 64 is a flowchart illustrating steps of an example use case oftitrating stimulation therapy based at least on a user's glucose statusdata, in accordance with an embodiment of the present specification;

FIG. 65 is a flowchart illustrating steps of yet another example usecase of titrating stimulation therapy based at least on a user's glucosestatus data, in accordance with an embodiment of the presentspecification;

FIG. 66 is a flowchart illustrating steps of yet another example usecase of titrating stimulation therapy based at least on a user's glucosestatus data, in accordance with an embodiment of the presentspecification;

FIG. 67 is a flowchart illustrating steps of yet another example usecase of titrating stimulation therapy based at least on a user's glucosestatus data, in accordance with an embodiment of the presentspecification;

FIG. 68 is a flowchart illustrating steps of yet another example usecase of titrating stimulation therapy based at least on a user's glucosestatus data, in accordance with an embodiment of the presentspecification;

FIG. 69 is a flowchart illustrating steps of still another example usecase of titrating stimulation therapy based at least on a user's glucosestatus data, in accordance with an embodiment of the presentspecification;

FIG. 70 is a flow chart illustrating a plurality of steps involved in anembodiment of a method of using an EDP device to automatically generateone or more interventions based on identified health trends of a user;

FIG. 71 is a linearly sloping weight trend with reference to a user'starget weight loss goal, in accordance with an embodiment of the presentspecification;

FIG. 72A illustrates a first heat map plotted with icons or dotsindicative of appetite data for a first period of time, in accordancewith an embodiment of the present specification;

FIG. 72B illustrates a second heat map plotted with icons or dotsindicative of appetite data for a second period of time, in accordancewith an embodiment of the present specification;

FIG. 73 illustrates a plurality of waveforms or pulses includingsymmetric and asymmetric, biphasic, charge-balanced waveforms generatedby the EDP device, in accordance with embodiments of the presentspecification;

FIG. 74A illustrates a train of symmetric biphasic charge-balancedpulses, in accordance with embodiments of the present specification;

FIG. 74B illustrates a train of asymmetric biphasic charge-balancedpulses, in accordance with embodiments of the present specification;

FIG. 74C illustrates another train of symmetric biphasic charge-balancedpulses, in accordance with embodiments of the present specification;

FIG. 74D illustrates another train of asymmetric biphasiccharge-balanced pulses, in accordance with embodiments of the presentspecification;

FIG. 75A is a flowchart illustrating a plurality of steps for generatinga train of biphasic pulses, in accordance with embodiments of thepresent specification;

FIG. 75B is a flowchart illustrating a plurality of steps for generatinga train of biphasic pulses, in accordance with alternate embodiments ofthe present specification; and

FIG. 76 illustrates a VAS configured as a color spectrum for assessingan intensity of hunger or appetite, in accordance with an embodiment ofthe present specification.

DETAILED DESCRIPTION

The present specification is directed toward systems and methods ofmodulating a patient's appetite, hunger, satiety level, satiation level,or fullness level by delivering electrical stimulation to apredetermined area of the user's anatomy in a manner that is convenient,easy to use, and amenable to increased patient compliance. Moreparticularly, the present specification relates to electricalstimulation devices comprising low profile, wearable, disposable skinpatches that are configured for placement on a patient's front, lateraland/or back T2 to T12 and/or C5-T1 dermatomes, easy to self-administer,programmable and monitorable using a mobile handheld device, andprogrammed to stimulate, from the external surface of the patient'sepidermal layer through a range of 0.1 mm to 10 mm of the dermis orthrough a range of 0.1 mm to 20 mm of the dermis, nerves locatedproximate to the front, lateral and/or back T2 to T12 and/or C5-T1dermatomes in a manner that enables modulation of a patient's appetite,hunger, satiety level, satiation level or fullness level, and thatavoids nausea, dyspepsia and minimizes habituation. In variousembodiments, a stimulation depth through the patient's epidermal layerranges from 0.1 mm to 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13,14, 15, 16, 17, 18, 19, 20 mm or any increment therein. The presentspecification further relates to a low profile, wearable, disposableskin patch that is capable of integrating with, and being controlled by,a plurality of different hardware devices or software applicationsdepending on the type, extent, nature and scope of the appetite, hunger,satiety level, satiation level or fullness level modulation desired,including immediate, large weight loss or long term weight maintenance.

An electrical neuro-stimulation device, in the form of an electro-dermalpatch (EDP) is disclosed that, in various embodiments, is configured asa discrete, disposable and waterproof adhesive patch or pad forplacement on a user's skin, particularly on the regions encompassing thefront, lateral and/or back T2-T12 dermatomes and/or C5-T1 dermatomes. Invarious embodiments, the EDP is wireless and incorporates flexiblecircuits and elastomeric overmolding, making the device waterproof andflexible enough to be able to mold to body contours for greater comfortand permanent wearability. In some embodiments, the EDP device alsomodulates ghrelin production.

In accordance with various aspects of the present specification, theresultant benefits of modulating appetite, hunger, satiety level,satiation level or fullness level include treating conditions associatedwith persons who are overweight or those with metabolic syndrome,treating obesity and T2DM prevention or management. In accordance withvarious aspects of the present specification, the electro-dermal patchdevice treats people having a BMI (Body Mass Index) of 25 or greater(overweight being 25-30, obese being 30 and above, and morbid obesitybeing above 35). In embodiments of the present specification, theelectro-dermal patch device is wearable and can be controlled andprogrammed by the patient, allowing the patient to administer therapyand eliminating the need for frequent patient visits to a medicalprofessional. In embodiments, the electro-dermal patch device isdesigned to be placed on the front, lateral and/or back thoracicdermatomes and/or C5-T1 dermatomes of the patient. Therefore, thepatient is able to place the electro-dermal patch device on him orherself, without the assistance of a medical professional.

In embodiments, the electro-dermal patch device is wirelessly coupled toa companion device (e.g. smartphone, watch, glove, wristband or tablet)which can be used to program the electro-dermal patch device, allowingthe patient to self-administer therapy on-demand. In some embodiments,all therapy provided by the electro-dermal patch device is coupled witha storage or recording (for keeping a log of the therapy) and patientcompliance reminders. The benefits provided by having a wearable andself-administered electro-dermal patch device include, among others,greater patient independence and improved patient compliance tostimulation protocols, with resultant increased dietary compliance andoverall efficacy, and the ability to modify stimulation parameters basedon real-time feedback provided to the electro-dermal patch device by thepatient and other devices. In some embodiments, the electro-dermal patchdevice is driven by an algorithm derived from patient input data andmonitored data (e.g. exercise monitored by a separate device).Adjustments to the algorithm, and therefore stimulation, are made bothmanually by the patient and automatically by the device itself or thecompanion device. In some embodiments, the electro-dermal patch deviceis driven by an algorithm derived from patient input data and monitoreddata (e.g. exercise monitored by a separate device). In someembodiments, the algorithm is also derived from monitored parameters,such as leptin (for ghrelin suppression), glucagon-like peptide 1(GLP-1), hemoglobin A1C, and blood glucose levels (for diabetestreatment), lipids, and triglycerides. These parameters are measured atbaseline and over time during treatment and are used as inputs totitrate therapy. Adjustments to the algorithm, and thereforestimulation, are made either manually by the patient or automatically bythe electro-dermal patch device itself or the companion device or both.In accordance with some aspects of the present specification, a medicalprofessional can flexibly program the electro-dermal patch and stilldirect the patient, only allowing the patient to adjust deviceparameters (for greater patient independence) but within restrictedbounds or predetermined parameters.

The present specification is directed towards multiple embodiments. Thefollowing disclosure is provided in order to enable a person havingordinary skill in the art to practice the invention. Language used inthis specification should not be interpreted as a general disavowal ofany one specific embodiment or used to limit the claims beyond themeaning of the terms used therein. The general principles defined hereinmay be applied to other embodiments and applications without departingfrom the spirit and scope of the invention. Also, the terminology andphraseology used is for the purpose of describing exemplary embodimentsand should not be considered limiting. Thus, the present invention is tobe accorded the widest scope encompassing numerous alternatives,modifications and equivalents consistent with the principles andfeatures disclosed. For purpose of clarity, details relating totechnical material that is known in the technical fields related to theinvention have not been described in detail so as not to unnecessarilyobscure the present invention.

For purposes of the present specification, the terms “trigger” and“triggering” do not necessarily imply immediately triggeringstimulation. “Trigger” and “triggering” are defined as initiating orstarting the execution of a protocol that will result in stimulationover a predefined period.

The term “modulating” refers to any form of regulation, manipulation orcontrol to change a given variable from one state to another state.

In the description and claims of the application, each of the words“comprise” “include” and “have”, and forms thereof, are not necessarilylimited to members in a list with which the words may be associated. Itshould be noted herein that any feature or component described inassociation with a specific embodiment may be used and implemented withany other embodiment unless clearly indicated otherwise.

As used herein, the indefinite articles “a” and “an” mean “at least one”or “one or more” unless the context clearly dictates otherwise.

The terms “patient”, “individual”, “person”, and “user” are usedinterchangeably throughout this specification and refer to the personthat is receiving treatment or stimulation from the devices and methodsof the present specification.

The term “hunger” is defined as a physical sensation indicative of aperson's physical need for food and may be related to low levels ofglucose in the person's blood and/or concentrations of ghrelin and/orhunger-inducing gut hormones.

The term “appetite” is defined as a desire for food, possibly promptedby an emotional, psychological, and/or sensory reaction to the look,taste, or smell of food.

The term “satiation” is defined as a sensation of fullness that resultsin cessation of eating.

The term “fullness” is defined as a sensation of an adequate amount offood present in the stomach. It should be appreciated that the term“fullness” refers to a psychological or perceptive sensation by thepatient, which may be objectively measured using the scales describedherein. The term “physiological fullness” shall refer to a physicalmeasurement of the actual contents of a person's stomach.

The term “satiety” is defined as a sense of fullness that prolongs thetime between meals (the more satiety, the longer duration between twomeals). It is intended to refer to a patient's perception of a sense offullness that prolongs the time between meals.

The phrase “change in satiety” is defined as an alteration in thepatient's perception of gastric fullness or emptiness.

The term “dietary compliance” is defined as a patient's ability toadhere to a prescribed regimen of caloric intake, whether defined interms of total permissible calories or a type or amount of nutritionalintake, or some combination thereof, in order to achieve a targeteddaily, weekly, or monthly calorie consumption and/or a targeted type oramount of nutritional intake.

The phrase “weight maintenance” means adjusting an appetite or hungersuppression/decrease goal in order to maintain a certain amount ofweight loss that has already been achieved and to now avoid gainingweight. In some embodiments, weight loss maintenance entails engaging ina surgical procedure (such as various bariatric surgeries), applying theEDP of the present specification and using appetite or hungersuppression/decrease in order to maintain the weight loss achieved bysurgery.

The term “microbiota” is defined as an ensemble of microorganisms thatreside in a previously established environment, such as the stomach orgastrointestinal system. The term “gut microbiota” or “gut flora is thename given to the microbiota living in a person's intestine.

The term “glycemic index (GI)” is defined as a number associated with aparticular type of food that indicates the food's effect on a person'sblood glucose (also called blood sugar) level. A value of 100 representsthe standard, an equivalent amount of pure glucose. The glycemic indexis calculated by determining the incremental area under the bloodglucose response curve of a specific portion of a test food expressed asa percent of the response to the same amount of carbohydrate from astandard food taken by the same subject.

The term “glycemic load (GL)” is defined as the glycemic indexmultiplied by grams of carbohydrate per serving size. GL is based on aspecific quantity and carbohydrate content of a test food and calculatedby multiplying the weighted mean of the dietary glycemic index by thepercentage of total energy from the test food. When the test foodcontains quantifiable carbohydrates, the GL=GI(%)×grams of carbohydrateper serving.

The terms “epidermal layer” and “epidermis” are used interchangeablythroughout this specification and refer to the outermost, protective,nonvascular layer of a person's skin, covering the dermis and shall beconstrued to cover all variants of the word “epidermal”.

The term “power source” is used to represent any energy providingdevice, including a lithium-ion battery, a betavoltaic battery, a solarcell, nickel-cadmium battery, a fuel cell, a mobile phone, or remotecharging station.

The term “controller” is used to denote a processing unit configured tocontrol the initiation of stimulation, termination of stimulation, andtype and/or extent of stimulation and shall include the terms “controlunit”, “processing unit”, “microcontroller”, “microprocessor”, or“processor”.

The term “pulse generator” means a device configured to generateelectrical pulses in accordance with instructions from a controller. Itshould be appreciated that the pulse generator and controller can beintegrated into a single device or multiple devices.

The term “electrode” is used to refer to a conducting material that iscapable of receiving electrical pulses and communicating them to anothersurface.

The term “modulation” or “modulating” means any form of regulation,manipulation or control to change a given variable from one state toanother state.

Any increases or decreases in levels or rates are determined by thefollowing formula [(New Level or Rate)−(Old Level or Rate)]/(Old Levelor Rate).

The phrase “at least one of x, y, and z” means that only one of x or yor z need to be true or present in order to satisfy that limitation.

The term “dermatome” refers to an area of skin that is primarilyinnervated and/or supplied by a specific spinal nerve.

The term “meridian” refers to low resistance fluid channels wherevarious chemical and physical transports take place and are individualpathways which exist among the subcutaneous tissues and serve aschannels for the flow of interstitial microscopic fluid throughout thebody.

The term “big data” refers to voluminous amount of structured,semi-structure and unstructured data that has the potential to be minedand analyzed for patterns and information.

The term “bolus” refers to a discrete, single dosage of stimulation thatis given in one instance in contrast to “constant stimulation” thatrefers to a certain intensity of stimulation that is delivered over acertain period of time at a constant rate.

The term “gastric emptying time” is defined as the time it takes toempty a predefined percentage of the patient's stomach contents, such as25%, 50%, 75%, or 95%. Measures of gastric emptying time are establishedassuming the same composition of a known bolus of food. Therefore, whereone is comparing a post-prandial time to empty 50% of the patient'sstomach contents with stimulation to a post-prandial time to empty 50%of the patient's stomach contents without applying stimulation sessions,the comparison presumes a situation where the patient has consumed theexact same composition of food and liquid.

The term “direct electrical stimulation” of a given anatomical structureshall mean encompassing the anatomical structure in an electrical fieldgenerated by the electrical stimulation.

The term “meal” refers to any of the regular occasions in a day when anamount of solid or liquid food is eaten, such as breakfast, lunch, ordinner, and including various snacks therebetween.

The term “gastric retention” refers to a measure of how much content isleft in the stomach after a predefined period of gastric activity.

The terms “server”, “server(s)” and “at least one server” refer to oneor more servers, including a cloud configuration where a specificindividual server may not be identifiable.

The term “interneuron” is defined as a broad class of neurons found inthe human body. Interneurons create neural circuits, enablingcommunication between sensory or motor neurons and the central nervoussystem (CNS).

The term “metabolic or health state” of a patient refers to at least oneor any sub-set or combination of the following therapeutic parametersthat define the physiology of the patient: an amount or rate of antralmotility, gastric motility, gastric emptying time, gastric retention,gastric accommodation or distention, appetite or hunger level; satiety,satiation or fullness levels; compliance with a target daily caloricintake or dietary compliance; quality of sleep; glucagon-like peptide 1(GLP-1), leptin, serotonin, peptide YY, beta-endorphin levels, restingmetabolic rate, cholecystokinin; total body weight; total weight loss,excess weight loss; well-being level; pre and post-prandial ghrelinlevel; acyl-ghrelin; total ghrelin; triglycerides, cholesterol,lipopolysaccharides, motilin-related peptide or plasma motilin levelpeak value; degree of glycemia, glycemia peak; glucose level of anon-diabetic or a non-pre-diabetic patient, postprandial plasma glucoseconcentration of a pre-diabetic and diabetic patient, glycemic control,fasting blood or plasma glucose; hemoglobin A1C; glucose homeostasis,HOMA-IR (Homeostasis Model Assessment—estimated Insulin Resistance);fasting plasma insulin level; degree of insulin resistance; gutmicrobiota; metabolism rate (such as RMR or BMR); perception of gastricfullness or emptiness; exercise output, defined as the amount ofcalories burned in a given time period or steps taken in a given timeperiod; hepatic gluconeogenesis; prolactin level; dopamine level; and/orplasma cytokeratin 18 (CK-18).

The term “real-time” refers to the concurrence in time between twoevents. For example, if a dietary intervention is described as beingprovided in “real-time” relative to the acquisition of appetite data, itmeans that the dietary intervention occurs within 24 hours, preferably12 hours, preferably 6 hours, preferably 1 hour, or any incrementtherein, of acquiring appetite data. This is contrast to patient diariesthat acquire data over the course of weeks and then, modifying therapybased on long term data collection.

Electro-Dermal Patch System

FIG. 1A is a block diagram illustration of a system 100 for stimulatingor modulating nerves and nerve endings in body tissues, in accordancewith an embodiment of the present specification. The system 100comprises an electro-dermal patch (EDP) device 110 in data communicationwith a companion device 105. In various embodiments, the companiondevice 105 is further capable of being in data communication with aremote patient care facility, data server and/or patient care personnel.The companion device 105, comprising a computer readable medium andprocessor, can be any type of computing and communication device,including a computer, server, mobile phone, gateway, laptop, desktopcomputer, netbook, personal data assistant, remote control device or anyother device capable of accessing a cellular, Internet, TCP/IP,Ethernet, Bluetooth, wired, or wireless network.

The electro-dermal patch device 110, in various embodiments, has ahousing 111 comprising a microprocessor or microcontroller 112electronically connected to a transceiver 114 to wirelessly communicatewith the companion device 105, a pulse generator 116 to generate aplurality of electrical pulses for application through one or moreelectrodes 118 and a power management module 120, such as a lithium-ionbattery, a betavoltaic battery, a solar cell, nickel-cadmium battery, ora fuel cell. In some embodiments, the power management module 120comprises a battery having a voltage in a range of 1.5 V to 4.5 V (for asingle battery). The voltage depends on the chemistry of the batterybeing used. In other embodiments, the power management module 120includes a plurality of batteries stacked in series to increase thevoltage supply, wherein per battery voltage ranges from 1.5 V to 4.5 V.The power management module 120 has one or more additional receptorslots 130 to enable snap on or clip on attachment of a disposableelectronic assembly that includes a battery for providing additionalbackup charge to the electro-dermal patch device 110.

Optionally, the housing 111 also comprises one or more actuators 122such as push buttons or switches to switch the device 110 on/off and toenable user control or settings of a plurality of stimulation therapyprotocols such as for, but not limited to, toggling stimulation up ordown, one or more visual indicators 124, such as LEDs (Light EmittingDiodes), and one or more tactile and audio indicators 126, such as avibrator, buzzer or beeper to provide feedback to a user, such as aboutthe on/off state of the electro-dermal patch device 110, commencement orconclusion of therapy, battery charge/discharge, and/or malfunction ofthe electro-dermal patch device 110, among other information. In oneembodiment, the one or more actuators 122 includes a touch sensitivescreen that enables (using an accelerometer) the user to finger-tap tocontrol and adjust stimulation therapy protocols while theelectro-dermal patch device 110 is still worn by the user. Still furtherembodiments may include (additionally or alternatively) controlinterfaces on the EDP such as, but not limited to, a slider on thesurface of the EDP, an infrared interface wherein communication betweenthe EDP 110 and the companion device 105 is achieved by transmission ofinfrared radiation, a magnetic interface wherein an external magnet orelectro-magnet activates a reed switch or GMR (giant magnetoresistance)device or sensor positioned on the EDP 110, or an audible (speaker)command input interface.

In various embodiments, the EDP 110 is programmable and controlleddirectly, that is without the companion device 105, such as, but notlimited to, by actuating one or more buttons (actuators 122) to enableuser control or settings of a plurality of stimulation therapy protocolsand parameters (for example, a pre-defined number of presses of a buttonmay correspond to a predefined functional setting of the EDP); byissuing predefined voice based commands to an audible (speaker) commandinput interface of the EDP or via an Intelligent Personal Assistant(IPA) system (described with reference to FIG. 48A through C) that maybe in direct communication with the EDP 110; or by issuing commandsthrough pre-defined physical body movements, such as (for example)haptic motions of the wrist or hand, when the user is wearing the EDP110 configured as a wristwatch or wristband (such as the band 2105 ofFIG. 21A or the wristwatch 2106 of FIG. 21B and that also includes anaccelerometer or inclinometer to detect, capture and acquire the user'shaptic motions).

It should also be appreciated that, in one embodiment, the EDP comprisesno such on/off actuators or stimulation toggling actuators and isentirely controlled by an external device, as described below.

In various embodiments, the housing 111 is sealed so that it iswaterproof or water-resistant. In some embodiments, the housing 111 ishermetically sealed to be airtight. In various embodiments, the housing111 is molded from polymeric materials such as, but not limited to,polyolefins, PET (Polyethylene Terephthalate), polyurethanes,polynorbornenes, polyethers, polyacrylates, polyamides (Polyether blockamide also referred to as Pebax®), polysiloxanes, polyether amides,polyether esters, trans-polyisoprenes, polymethyl methacrylates (PMMA),cross-linked trans-polyoctylenes, cross-linked polyethylenes,cross-linked polyisoprenes, cross-linked polycyclooctenes,inorganic-organic hybrid polymers, co-polymer blends with polyethyleneand Kraton®, styrene-butadiene co-polymers, urethane-butadieneco-polymers, polycaprolactone or oligo caprolactone co-polymers,polylactic acid (PLLA) or polylactide (PL/DLA) co-polymers,PLLA-polyglycolic acid (PGA) co-polymers, and photocrosslinkablepolymers. In some embodiments, the housing 111 is of transparentpolymeric material to allow visibility of the contained electroniccomponents and circuitry.

In various embodiments, the microprocessor 112 is in electroniccommunication with one or more sensors 135 to generate datarepresentative of various physiological parameters of an individual,such as the individual's heart rate, pulse rate, beat-to-beat heartvariability, EKG or ECG, respiration rate, skin temperature, core bodytemperature, heat flow off the body, galvanic skin response or GSR, EMG,EEG, EOG, blood pressure, body fat, hydration level, activity level,oxygen consumption, glucose or blood sugar level, body position,pressure on muscles or bones, and/or UV radiation exposure andabsorption. In certain cases, the data representative of the variousphysiological parameters are the signal or signals themselves generatedby the one or more sensors 135 and in certain other cases the data iscalculated by the microprocessor 112 based on the signal or signalsgenerated by the one or more sensors 135. Methods for generating datarepresentative of various physiological parameters and sensors to beused therefor are well known to persons of ordinary skill in the art.

Table 1 provides several examples of well-known parameters and thesensor used to measure the parameter. The types of data listed in Table1 are intended to be examples of the types of data that can be generatedby the one or more sensors 135. It is to be understood that other typesof data relating to other parameters can be generated by theelectro-dermal patch device 110 without departing from the scope of thepresent specification. It is further understood that the sensors may belocated in the housing 111, as shown in FIG. 1A, or remotely positionedfrom the housing 111 and configured to be electronic communication, viathe wireless transceiver 114, with the microcontroller 112.

TABLE 1 Parameter Sensor Heart Rate/Pulse Rate EKG (2 Electrodes)/BVP(LED Emitter and Optical Sensor) Beat-to-Beat Variability EKG (2Electrodes) EKG Skin Surface Potential EKG (3-10 Electrodes) RespirationRate Chest Volume Change (Strain Gauge) Skin Temperature SurfaceTemperature Probe (Thermistors) Core Temperature Esophageal or RectalProbe (Thermistors) Heat Flow Heat Flux (Thermopile) Galvanic SkinResponse Skin Conductance (2 Electrodes) EMG Skin Surface Potential EMG(3 Electrodes) EEG Skin Surface Potential EEG (Multiple Electrodes) EOGEye Movement Thin Film Piezoelectric Sensors Blood Pressure ElectronicSphygmomanometer Body Fat Body Impedance (2 Active Electrodes) ActivityAccelerometer Oxygen Consumption Oxygen Uptake (Electro-chemical)Glucose Level Electro-chemical sensors, Optical techniques, Aqueoustechniques (tears, saliva, and sweat), and Iontophoresis techniques.Body Position Mercury Switch Array, Accelerometer Muscle Pressure ThinFilm Piezoelectric Sensors UV Radiation UV Sensitive Photo Cells Bloodoxygen saturation Pulse oximeter

The microprocessor 112 is programmed to summarize and analyze the datarepresentative of the physiological parameters of the individual. Forexample, the microprocessor 112 can be programmed to calculate anaverage, minimum or maximum heart rate or respiration rate over adefined period of time, such as ten minutes. The electro-dermal patchdevice 110 is also able to derive information relating to theindividual's physiological state based on the data representative of oneor more physiological parameters. The microprocessor 112 is programmedto derive such information using known methods based on the datarepresentative of one or more physiological parameters. Table 2 providesexamples of the type of information that can be derived, and indicatessome of the types of data that can be used therefor.

TABLE 2 Derived Information Data Used Activity level Heart rate, pulserate, respiration rate, heat flow, activity, oxygen consumption Basalmetabolic rate Heart rate, pulse rate, respiration rate, heat flow,activity, oxygen consumption, glucose level Basal temperature Skintemperature, core temperature Calories burned Heart rate, pulse rate,respiration rate, heat flow, activity, oxygen consumption Maximum oxygenEKG, heart rate, pulse rate, respiration rate, heat flow, bloodconsumption rate pressure, activity, oxygen consumption Relaxation LevelEKG, beat-to-beat variability, heart rate, pulse rate, respiration rate,skin temperature, heat flow, galvanic skin response, EMG, EEG, bloodpressure, activity, oxygen consumption Sleep onset/wake Beat-to-beatvariability, heart rate, pulse rate, respiration rate, skin temperature,core temperature, heat flow, galvanic skin response, EMG, EEG, EOG,blood pressure, oxygen consumption Stress level EKG, beat-to-beatvariability, heart rate, pulse rate, respiration rate, skin temperature,heat flow, galvanic skin response, EMG, EEG, blood pressure, activity,oxygen consumption

Additionally, the electro-dermal patch device 110 may also generate dataindicative of various contextual parameters relating to the environmentsurrounding the individual. For example, the electro-dermal patch device110 can generate data representative of the air quality, soundlevel/quality, light quality or ambient temperature near the individual,or the global positioning of the individual. The electro-dermal patchdevice 110 may include one or more sensors for generating signals inresponse to contextual characteristics relating to the environmentsurrounding the individual, the signals ultimately being used togenerate the type of data described above. Such sensors are well known,as are methods for generating contextual parametric data such as airquality, sound level/quality, ambient temperature and globalpositioning.

In one embodiment, the electro-dermal patch device 110 includes at leastone or a combination of the following three sensors 135: 1) an impedanceor bio-impedance sensor to determine electrode integrity, i.e. whetherthe electrode is functioning properly or damaged, to detect and confirmcontact integrity of the one or more electrodes 118 with tissues to bestimulated, or to estimate body fat or Body Mass Index (BMI) andaccordingly modify or manage stimulation therapy. In another embodiment,a first impedance or bio-impedance sensor is used to detect and confirmcontact integrity of the one or more electrodes 118 with tissues to bestimulated and a second impedance or bio-impedance sensor is used toestimate body fat or Body Mass Index (BMI), 2) an accelerometer orinclinometer to monitor user activity such as walking, running,exercises, distance covered, sleep quality, including sleep duration,detection and monitoring, sensing user input to the electro-dermal patchdevice 110, 3) a neural activity monitor to detect presence of neuralactivity as well as an amount of neural activity (firing rate).

In one embodiment, the electro-dermal patch device 110 only includes oneor a combination of the following three sensors 135, and no othersensors: 1) an impedance or bio-impedance sensor to determine electrodeintegrity, i.e. whether the electrode is functioning properly ordamaged, to detect and confirm contact integrity of the one or moreelectrodes 118 with tissues to be stimulated, or to estimate body fat orBody Mass Index (BMI) and accordingly modify or manage stimulationtherapy. In another embodiment, a first impedance or bio-impedancesensor is used to detect and confirm contact integrity of the one ormore electrodes 118 with tissues to be stimulated and a second impedanceor bio-impedance sensor is used to estimate body fat or Body Mass Index(BMI), 2) an accelerometer or inclinometer to monitor user activity suchas walking, running, exercises, distance covered, sleep quality,including sleep duration, detection and monitoring, sensing user inputto the electro-dermal patch device 110, 3) a neural activity monitor todetect presence of neural activity as well as an amount of neuralactivity (firing rate). With respect to confirming contact integrity, itshould be appreciated that, in one embodiment, sufficient contactintegrity of the one or more electrodes 118 is defined in terms ofachieving a predefined amount of electrode impedance with the patient'sepidermal layer, such as in the range of 200 to 1000 ohms, as measuredby the impedance sensor.

The neural sensor is used to generate a plurality of feedback such as,but not limited to, an indication that the electro-dermal patch device110 is placed in the right location or area, an indication that theelectro-dermal patch device 110 is increasing neural-activity in linewith, and in accordance with, a stimulation protocol or an indicationthat the neural response rate is too slow or insufficient and,therefore, the stimulation protocol needs to be modified. Such pluralityof feedback generated by the neural sensor is provided to the userthrough a Health Management software application running on the user'shand-held computing device such as a smartphone, PDA, tablet that, invarious embodiments, functions as the companion device 105. In someembodiments, the neural sensor connects to at least one of the one ormore stimulation electrodes 118 while in some alternate embodiments, theneural sensor connects to at least one additional sensing electrode inaddition to the one or more stimulation electrodes 118. In someembodiments, the electro-dermal patch device 110 also integrallyincludes a glucose sensor to monitor the user's blood glucose level. Insome embodiments, the glucose sensor is configured as a standalone thirdparty device in wireless communication with the Health Managementapplication of the present specification.

In some embodiments, the electrodes 118 are in the housing 111, while inother embodiments, the electrodes 118 are removably connectable to thehousing 111. In one embodiment, the electrodes 118 are configured to bepartially or wholly positioned in the housing 111 and extend outward tobe in electrical communication with a hydrogel pad (for example, asdescribed with reference to FIGS. 4D-4S). In another embodiment, theelectrodes 118 are configured to be snap-on electrodes where theelectrodes 118 are removably connectable to an exterior surface of thehousing 111. This allows for the electrode 118 and/or hydrogel pad to beremoved and replaced with a new electrode 118 and hydrogel pad, therebyreusing the electrical dermal patch device 110 with the new electrodeand hydrogel pad and minimizing the cost of electrodes that fail afterjust a few days of use. In yet another embodiment, the electrodes 118are configured to be removably connectable to the exterior surface ofthe housing 111 using at least one magnet. Use of magnet(s) requires theuser to use minimal force or effort to re-attach the electrodes 118 tothe housing 111 as compared to a snap-on configuration.

FIG. 1B is a block diagram illustration of a system 141 for stimulatingor modulating nerves and nerve endings in body tissues, in accordancewith another embodiment of the present specification. In someembodiments, referring to FIG. 1B, the electro-dermal patch device (EDP)140 includes a microcontroller 142, wireless transceiver 144, a powermanagement module 150, such as a lithium-ion battery, a betavoltaicbattery, a solar cell, nickel-cadmium battery, or a fuel cell, a pulsegenerator 146, and at least one electrode 148, and includes no otherphysical inputs or sensors on the EDP 140 itself. The remaining inputsare on the companion device 105 and are actuated through the wirelesscoupling of the companion device 105 and EDP 140.

In some embodiments, rather than including a physical on/off switch, theEDP 140 depicted in FIG. 1B is always using at least a minimum amount ofpower such that an ‘off’ state refers to a low power state. While nostimulation is being provided, there is, at a minimum, a periodic‘wake-up’ of the EDP 140 to check for communication from the companiondevice 105. The ‘wake-up’ places the device in an ‘on’ state and, insome embodiments, includes no stimulation wherein the EDP 140 runsdiagnostics for reporting to the companion device 105. Therefore, whilein the ‘off’ state, the EDP 140 is constantly using a very low amount ofpower, is not providing stimulation, and is either awaiting a signalfrom the companion device or is performing diagnostics or othernon-stimulation activities requiring very little power. In someembodiments, the energy usage is less than 5 μA average current or inthe range of 0.1 μA to 5 μA average current while in the ‘off’ state andgreater than 10 μA average current while in the ‘on’ state. In someembodiments, the energy usage is at least 1 μA greater while in the ‘on’state than while in the ‘off’ state. Once the EDP 140 receives a signalfrom the companion device 105 to initiate stimulation, it enters the‘on’ state and uses an amount of energy associated with the level ofstimulation. In another embodiment, the EDP 140 uses no energy while inan ‘off’ state and must be awakened, or switched to an ‘on’ state, by asignal from the companion device.

FIG. 1C is a block diagram illustration of a system 161 for stimulatingor modulating nerves and nerve endings in body tissues, in accordancewith yet another embodiment of the present specification. In someembodiments, referring to FIG. 1C, the electro-dermal patch device (EDP)160 includes a microcontroller 162, wireless transceiver 164, a powermanagement module 170, such as a lithium-ion battery, a betavoltaicbattery, a solar cell, nickel-cadmium battery, or a fuel cell, a pulsegenerator 166, one electrode 168, an optional single actuator 172 toturn the EDP 160 on or off, one sensor 175 for sensing a physiologicalparameter of the patient, and includes no other physical inputs on theEDP 160 itself. In one embodiment, the sensor 175 is a neural sensor.The remaining inputs are on the companion device 105 and are actuatedthrough the wireless coupling of the companion device 105 and EDP 160.

In accordance with various aspects of the present specification, eachcomponent (power management module, microprocessor or microcontroller,pulse generator, transceiver, and one or more electrodes) of theelectro-dermal patch may be positioned in a separate housing, in aseparate device, or otherwise physically remote from each other. Forexample, as described with reference to FIG. 1A, the electro-dermalpatch device 110 comprises a power management module 120, microprocessoror microcontroller 112, pulse generator 116, transceiver 114, and one ormore electrodes 118 in a housing 111, where the one or more electrodes118 are in physical communication with a hydrogel pad.

However, in a first alternative embodiment as shown in FIG. 1D, theelectro-dermal patch device 180 comprises a transceiver 182 having anantenna 184 for receiving electrical pulse signals 186 and an electrode183, which may or may not be in physical contact with a hydrogel pad. Ahousing 181 may be positioned around the transceiver 182 and electrode183 or a substrate carrier may be used to support a low-profiletransceiver and/or electrode circuit without any additional housingstructure. In this embodiment, an external device 185 comprises thepower source, controller, and pulse generator adapted to generate aplurality of electrical pulses, as described earlier with reference toFIGS. 1A through 1C. The external device 185 may be a watch, mobilephone, a sensor pod configured to attach to the patient using a strap orband, or other wearable device. The external device 185 wirelesslytransmits the electrical pulses 186 to the transceiver 182 which, inturn, transmits the electrical pulses to the electrode 183 and,thereafter, to the patient's epidermal layer through the hydrogel pad.

In a second alternative embodiment, as shown in FIG. 1E, the EDP device190 comprises a transceiver 182 having an antenna 184 for receivingsignals 196, a pulse generator 187, and an electrode 183 in physicalcommunication with a hydrogel pad. A housing 191 may be positionedaround the transceiver 182, pulse generator 187, and electrode 183. Inthis embodiment, an external device 192 comprises the power source andcontroller adapted to generate an electrical signal, power signal, ordata signal 196 that is wirelessly transmitted to transceiver 182 and,in turn, to the pulse generator 187 and used by the pulse generator 187to generate a plurality of electrical pulses. The external device 192may be a watch, mobile phone, a sensor pod configured to attach to thepatient using a strap or band, or other wearable device. The electricalpulses are communicated to the electrode 183 and, thereafter, to thepatient's epidermal layer through an optional hydrogel pad.

In a third alternative embodiment, as shown in FIG. 1F, the EDP device195 comprises a transceiver 182 having an antenna 184 for receivingpower signals 197, a microprocessor or microcontroller 193, a pulsegenerator 187, and an electrode 183 in physical communication with ahydrogel pad. A housing 194 may be positioned around the transceiver182, microcontroller 193, pulse generator 187, and electrode 183. Inthis embodiment, an external device 198 comprises a power source andtransceiver adapted to generate the power signal 197 that is wirelesslytransmitted to the transceiver 182 of the EDP device 195 and, in turn,to the microcontroller 193 and pulse generator 187 which generates aplurality of electrical pulses. The external device 198 may be a watch,mobile phone, a sensor pod configured to attach to the patient using astrap or band, or other wearable device. The electrical pulses arecommunicated to the electrode 183 and, thereafter, to the patient'sepidermal layer through an optional hydrogel pad.

In a fourth alternative embodiment, each of the power source,controller, pulse generator, transceiver, electrode, and hydrogel padare combined altogether in a single housing. In a fifth alternativeembodiment, the controller, pulse generator, and/or transceiver arecombined together in a first housing while the electrode, power source,and/or hydrogel pad are in a disposable second housing, thereby allowingthe electrode, power source, and hydrogel to be disposed of whenexhausted. Accordingly, the controller, pulse generator, and/ortransceiver could be reused and connected to a second electrode, powersource, and/or hydrogel pad, yielding a refreshed device.

It should be appreciated that each of the above embodiments can beimplemented without a transceiver, replacing the wireless communicationwith a wired connection between the external device and theelectro-dermal patch. It should also be appreciated that, for eachembodiment, signal processing to determine data indicative of aphysiological condition can be done at the sensor level, i.e. in theimpedance or other sensor, at the controller level in the EDP device, orat the external device level using a mobile application software orother program.

Electro-Dermal Patch (EDP) Device Configurations

Prior art TENS (Transcutaneous Electrical Neurostimulation) orelectrostimulation devices worn externally are not well suited forextended wear (such as, for more than a few hours). The stimulationtherapy of the present specification requires a wearable device that isattached to the user's skin during waking hours so as to enable aplurality of specific treatment protocols to the user, automaticallyover time. In order for this to be feasible, the EDP device of thepresent specification must possess a high level of extended wearabilitythat is not compromised by either the device falling off or by causingskin irritation or itching.

Thus, in accordance with an aspect of the present specification, theelectro-dermal patch device 110 is configured as a wearable anddisposable skin patch that is adhesively attached to the user's skin.Optionally, the EDP includes at least one or a pair of removable andreplaceable conductive hydrogel, hydrocolloid or foam pads and have anadhesive base surface covered by a tab (described with reference to FIG.2D) such that, when the tab is removed, the base surface can be adheredto the user's skin. Alternatively, the conductive hydrogel, hydrocolloid(contains gel-like components in an adhesive compound laminated onto aflexible, water-resistant outer layer) or foam pads (as described withrespect to FIG. 55M) are a permanent part of the electro-dermal patchdevice 110 and the entire assembly is disposed of once the batterydepletes. The hydrogel pads provide electrical conductivity from the EDPdevice to a user's skin surface. Hydrogel consists of a water basedabsorbing polymer and a water based electrolyte. Electrical current istransmitted to the skin via the electrolyte in the hydrogel. In variousembodiments, both the hydrogel and the electrolyte within meet therequirements of biocompatibility as defined by ISO 10993-5,10, which isincorporated herein by reference. In some embodiments, the EDP deviceuses ‘foam electrodes’ (or foam pads comprising polyethylene acrylicfoam adhesive) with either dry or wet conductive gels applied to thecenter of the electrode assembly. The foam is placed along the perimeterof the electrode assembly and provides adhesion to the skin. The gel isthe conductive medium between the electrode metal and the skin. The‘foam electrodes’ are impervious to water since the foam is closed celland acts as a barrier to water ingress to the conductive gel.

In accordance with an aspect of the present specification, theelectro-dermal patch device 110 is configured to be worn for prolongedusage, such as for at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13,14 days continuously or up to 3 months continuously or any incrementtherein, and removed solely for the purpose of recharging and/oroptionally changing the replaceable conductive hydrogel pads. Inaccordance with another aspect of the present specification, theelectro-dermal patch device 110 provides stimulation therapy while atthe same time minimizing skin irritation and related side effects suchas erythema (redness), scaling, pruritus (itching), stripping of stratumcorneum, adhesive irritation, bacterial infection related to occlusion(folliculitis), irritant contact dermatitis and intertrigo. It should benoted that obese people with belly rolls are particularly susceptible tointertrigo (Intertriginous dermatitis or Candida Albicans) which causesabdominal rashes and irritation. Therefore, the EDP device of thepresent specification uses electrodes that are suited for prolongedstimulation without promoting the aforementioned skin problems.

In some embodiments, the electrical dermal patch is adapted to becontinuously worn by a patient for at least 3 days and comprises ahousing comprising a controller in electrical communication with a pulsegenerator and at least two electrodes adapted to be adhered to thepatient's skin and in electrical communication with the pulse generator.The controller comprises programmatic instructions that, when executedand transmitted to the pulse generator, cause the pulse generator togenerate and transmit to the at least two electrodes a first set ofelectrical stimulation pulses and a second set of electrical stimulationpulses. Each of the at least two electrodes comprise a hypoallergenicconductive gel with at least one adhesive surface.

In other embodiments, the electrical dermal patch is adapted to becontinuously worn by a patient for at least 3 days and comprises ahousing comprising a controller in electrical communication with a pulsegenerator and at least two electrodes adapted to be adhered to thepatient's skin, positioned in a same plane parallel to the patient'sskin, separated by a distance of 0.05 cm² to 0.4 cm². and in electricalcommunication with the pulse generator, wherein the controller comprisesprogrammatic instructions that, when executed and transmitted to thepulse generator, cause the pulse generator to generate and transmit tothe at least two electrodes a first set of electrical stimulation pulsesand a second set of electrical stimulation pulses and wherein each ofthe at least two electrodes comprise a hypoallergenic conductive gelwith at least one adhesive surface, wherein the hypoallergenicconductive gel does not comprise imidazolidinyl urea or diazolidinylurea and wherein the at least one adhesive surface is adapted to adhereto the patient's skin and have a total skin contact surface area in arange of 2 cm² to 4 cm².

In one embodiment, a method of using the above described electricaldermal patch comprises programming the controller such that each of theelectrical stimulation pulses comprises a pulse width in a range of 10μsec to 10 msec, a pulse amplitude in a range of 100 μA to 100 mA, and apulse frequency in a range of 1 Hz and 100 Hz and evaluating if thepatient experiences a change in appetite as a result of an applicationof said first set of electrical stimulation pulses or said second set ofelectrical stimulation pulses to the patient's skin, wherein the patientdoes not experience erythema, scaling, pruritus, folliculitis, orintertrigo at a point where said two electrodes adhere to the patient'sskin.

Accordingly, in some embodiments, the EDP device uses self-adhesiveelectrodes or electrode pads having a contact surface (for contact tothe user's skin) made of a hypoallergenic conductive gel with at leastone adhesive surface and that has enough adhesive properties to stayattached to the user's skin for at least 12 hours. In embodiments, thehypoallergenic conductive gel is made from a hydrogel not containingknown allergens such as imidazolidinyl urea or diazolidinyl urea. Inembodiments, the gel is tested and approved as non-allergenic using IgEskin tests, specifically that the conductive gel registers either anegative IgE skin test or below a threshold value to thereby beconsidered as not triggering an allergic reaction. In some embodiments,the hydrogel is made from a modified carboxymethylcellulose polymer withpropylene glycol.

The adhesive of the pads is preferably biocompatible to prevent skinirritation due to prolonged usage of the patch. Loctite®, manufacturedby Henkel, is a non-limiting example of a medical or biocompatibleadhesive. The adhesive of the pads provides sufficient attachmentintegrity of the EDP to the user's skin. In various embodiments, the EDPhas an average minimum ‘peel strength’ in a range of 1.0 to 2.1 Newtonand preferably 1.5 Newton on living skin, allowing the EDP to be adheredto the skin for at least 8 hours of intensive activity, such asexercise. In one embodiment, the EDP device uses the KM30B hydrogel,manufactured by Katecho Inc., having a ‘peel strength’ in a range of 1to 2.5 Newton. Persons of ordinary skill in the art would appreciatethat ‘peel strength’ is the force required to remove or peel off theEDP, having adhesive pads, from the user's skin and is a measure of theattachment integrity of the EDP. ‘Peel strength’ is typically quantifiedby pulling the device from a flexible end or edge at an angle of 90degrees from the skin surface at a peel rate that ranges from 100 to 500mm/minute. In alternate embodiments, placement of the electro-dermalpatch device 110 is accomplished using a band, strap or a belt (forexample, at the user's abdomen, trunk, arm or wrist regions) without anyadhesive. In embodiments, the band, strap or belt is of a flexible orelastic material such as, but not limited to, Lycra or Spandex and holdsthe electro-dermal patch device 110 at a target location/region (such asthe abdomen, trunk, arm or wrist) by virtue of its elasticity. In someembodiments, the band, strap or belt is additionally or alternately heldin place using conventional fastening means such as, but not limited to,Velcro, clasps, or buckle fastening. In still other embodiments, theelectro-dermal patch device 110 is incorporated into a form fittinggarment such as a tight undershirt (for example, a Body Glove, Lycra orSpandex undershirt) which when worn by the user positions theincorporated electro-dermal patch device 110 at the desired dermatome.In embodiments, the electro-dermal patch device 110 is either directlyattached to the form fitting garment or is incorporated in the garmentas woven-in circuitry. It should be appreciated that the term “adhered”is intended to encompass all forms of achieving device-to-skin contact,including adhesives, bands, straps, or belts.

In accordance with some embodiments, the one or more electrodes 118enable the electro-dermal patch device 110 to provide electricalstimulation therapy, from the external surface of the patient'sepidermal layer through a range of 0.1 mm to 10 mm or a range of 0.1 mmto 20 mm of the dermis, to a user. In various embodiments, a stimulationdepth through the patient's epidermal layer ranges from 0.1 mm to 0.5,1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20,21, 22, 23, 24, or 25 mm or any increment therein. An embodiment of thepresent specification uses two electrodes disposed within hydrogel, foamor hydrocolloidal pads (also referred to, generically, as electrodepads). The electrode pads are disposed on the surface of the skin of theuser to pass electrical pulses through the skin and stimulate nerves andnerve endings in body tissues under the skin in the region of theelectrodes.

FIGS. 2A, 2B and 2C are respectively side, front and top perspectiveviews of an electro-dermal patch device 210, in accordance with anembodiment, having a pair of conductive hydrogel pads 220 and a devicehousing 213. The housing 213 includes the microcontroller, pulsegenerator, wireless transceiver, and power management module of thesystem described with reference to FIG. 1A. The electrodes extend fromthe housing 213 and into the pads 220 for placement proximate the skinsurface of a patient. In one embodiment, the pads 220 have at least oneand preferably two electrodes (not shown) disposed or printed on a lowersurface 222 of the pads 220. In some embodiments, the pads 220 have twoelectrodes, each disposed or printed in opposing halves of the lowersurface 222. In embodiments, a distance between the two electrodes isless than 20 mm, preferably less than 15 mm, preferably less than 10 mm,preferably less than 5 mm. In one embodiment, the distance between thetwo electrodes is about 4 mm. The pads 220, when adhered to a user'sskin, enable the electrodes to be in direct contact with the outersurface of the skin. It should be appreciated that while the electrodestouch the skin surface, the housing 213 remains above the skin surface.In some embodiments, the housing 213 remains within a range of 2 to 4mm, and preferably 2 mm above the skin surface. In various embodiments,the electrodes can be in the form of typical gel-based skin electrodes,gel-less skin electrodes, or skin puncturing or skin abrading electrodesin order to reduce skin-electrode impedance. In various embodiments, theelectrode surface area ranges from 0.1 inches² to 10 inches, 0.001inches² to 0.1 inches, or 0.001 inches² to 10 inches². In someembodiments, the total surface area taken up by the base of the twoelectrodes is less than 10 in² and preferably less than 5 in². In someembodiments, the total surface area taken up by the two electrodes isless that 10 in², preferably less than 8 in², and more preferably, 7 in²or less.

In some embodiments, hydrogel pads 220 of the electro-dermal patchdevice of the present specification are replaceable, enablingre-attachability of new conductive pads and therefore new adhesionsurfaces to the EDP device. FIG. 2D is an oblique perspective view of anelectro-dermal patch 230 with hydrogel removed and a replacementhydrogel 240 with liners 242, 243, in accordance with one embodiment ofthe present specification In accordance with an aspect of the presentspecification, used hydrogel pads can be peeled off the EDP device bypulling on a removal tab 241. In one embodiment, the removal tab 241 ismade from a white polyester film. On one side of this film there is anacrylic adhesive. When building the hydrogel and removal tab assembly,the acrylic side is placed facing the hydrogel on both the top andbottom. The replacement pad 240 is a custom shaped hydrogel, sandwichedbetween two pieces of transparent release liners 242, 243, in accordancewith an embodiment. An EDP-facing release liner 242 is peeled away. Thesecond piece of release liner 243, facing a skin surface, is used tohandle and locate the hydrogel 240 accurately onto the bottom of the EDP230. Light finger pressure is applied through the second release liner243 to insure good contact to the EDP 230. The second liner 243 is thenpeeled away thus exposing the working surface of the hydrogel.

In an alternate embodiment, referring again to FIGS. 2A-2C, the housing213 is detachable from the hydrogel pads 220 and can be snap-connectedto the hydrogel pads 220. In yet another embodiment, the hydrogel pads220 can be detachably connected to the housing 213 using at least onemagnet. Use of magnet(s) requires the user to use minimal force oreffort to detach and re-connect the hydrogel pads 220 and the housing213 as compared to a snap-on configuration.

The skin patches or pads 220 can have different shapes and sizes fordifferent body types and areas of stimulation. In some embodiments, thepatches or pads are irregularly shaped. In various embodiments, thepatches or pads 220 are rectangular having a length of about 2 inches, abreadth of about 1 inches and a thickness of about 0.2 inches. Inanother embodiment, the patches or pads 220 are rectangular having alength of about 3 to 5 inches, a breadth of about 0.5 to 2.5 inches anda thickness of about 0.10-0.30 inches. In various other embodiments, thepatches or pads 220 are round or circular having a diameter of about 2to 4 inches and a thickness of about 0.10 to 0.30 inches. In still otherembodiments, the patches or pads 220 are square having sides of about 2to 4 inches and a thickness of about 0.10 to 0.30 inches. The patches orpads 220 can have other sizes and shapes such as, but not limited to,elliptical or triangular. In other embodiments, the electrode/padcombination may have a shape including any one of irregular,rectangular, circular, square, elliptical, and triangular and wherein,at its widest, would between 0.25 to 5 inches in width, at its tallestwould be between 0.25 to 5 inches in height, and at its thickest wouldbe between 0.25 to 5 inches in thickness. In another embodiment, thedevice would comprise two of such electrode/pad combinations placed sideby side.

In accordance with various embodiments, the electrodes are disposed orprinted on the lower surface 222 of the pads 220 in the form of aplurality of patterns or geometries. FIGS. 3A and 3B illustrate,respectively, a first pattern 305 and a second pattern 310 of first 318,318′ and second electrodes 328, 328′. Referring to FIG. 3A, in oneembodiment, the electrodes 318, 318′ each have a ‘comb’ like patterncomprising an elongate ‘backbone’ 319, 319′ with a plurality of ‘teeth’317, 317′ extending perpendicularly therefrom. The two electrodes 318,318′ are positioned facing one another such that the ‘teeth’ 317 of afirst electrode 318 are configured to alternate between the ‘teeth’ 317′of a second electrode 318′. Referring to FIG. 3B, in one embodiment, theelectrodes 328, 328′ each have a ‘square wave’ pattern comprising aplurality of peaks 329, 329′ and valleys 327, 327′. In one embodiment,the peaks 329 of a first electrode 328 are wider than the peaks 329′ ofa second electrode 328′ such that the peaks 329′ of the second electrode328′ fit within the peaks 329 of the first electrode 328. Referring toFIGS. 3A and 3B simultaneously, the patterns 305, 310 are printed on thelower adhesive surface 322, 332 of skin patches or pads 320, 330.Persons of ordinary skill in the art should appreciate that the firstand second patterns 305, 310 are only exemplary. In some embodiments,the skin patches or pads 320, 330 are transparent such that the patternof electrodes 318, 318′, 328, 328′ are visible to the user through thepatches or pads 320, 330.

In accordance with various embodiments, the electrical field generatedby the electrodes, such as the electrodes 318, 318′, 328, 328′, isshallow and widely distributed to spread over a sufficiently large areaof application of a stimulation therapy. The characteristics of theelectrical field generated depend at least upon: a distance between theelectrodes and the pattern or geometry of the electrodes on the patch orpad. In accordance with an embodiment, the distance between the twoelectrodes 318, 318′ and 328, 328′ is fixed along the entire length ofthe electrodes 318, 318′, 328, 328′. In one embodiment, the electricalfield generated by the electrodes is distributed along an area ofattachment of the electro-dermal patch device and penetrates a depth ofup to 20 mm from the skin surface. In other words, in variousembodiments, the electrical field generated by the EDP device has awidth and length equal to the width and length of the device footprintand a depth sufficient to target neural tissue within 20 mm of thesurface of the skin.

FIG. 4A shows an electro-dermal patch device 410 configured to provideelectrical stimulation therapy, from the external surface of thepatient's epidermal layer through 10 mm or 20 mm of the dermis, inaccordance with some embodiments. In various embodiments, a stimulationdepth through the patient's epidermal layer ranges from 0.1 mm to 0.5,1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 mmor any increment therein. The electro-dermal patch device 410 includes ahousing 413, an electrode pad or skin patch (removed to enhancevisibility of electrode 411) for placing on the user's skin surface, andan electrode 411 in the form of an insulated fine wire 415 with bareddistal tip 416 extending from a bottom surface of the housing 413. Whenthe electro-dermal patch device 410 is placed on a patient, theelectrode 411 is disposed completely within the pad or skin patch anddoes not pierce, or directly contact, the skin of the patient. Thehousing 413 includes the microcontroller, pulse generator, wirelesstransceiver, and power management module of the system described withreference to FIGS. 1A through 1C.

FIGS. 4B and 4C are side and bottom perspective views respectively, ofanother embodiment of an electro-dermal patch device 420 of the presentspecification. The electro-dermal patch device 420 depicted in FIGS. 4Band 4C differs from the electro-dermal patch devices 210, 410 shown inFIGS. 2A-2C and FIG. 4A respectively, in that all of the components ofelectro-dermal patch device 420 are positioned in a single patch suchthat electro-dermal patch device 420 has a flat profile in contrast withelectro-dermal patch devices 210, 410 having a profile with a centrallyraised housing 213, 413. The lower profile of electro-dermal patchdevice 420 facilitates ease of use and placement by a patient. Invarious embodiments, the electro-dermal patch device 420 has a width wof 2 inches or less, a length l of 5 inches or less, and a height h of1.5 inches, preferably 0.35 inches or less. In some embodiments, theelectro-dermal patch device of the present specification has a height hof less than 1 inch, preferably less than ¾ inch, and more preferably, ½inch or less.

In various embodiments, the electro-dermal patch device 420 has a weightof 5 ounces or less.

In various embodiments, the electro-dermal patch device 420 has aningress protection rating (IPX) of at least IPX7, allowing the patientto take showers and swim for at least 30 minutes while theelectro-dermal patch device 420 is positioned on the body without waterdamage to the electro-dermal patch device 420. In some embodiments, thehydrogel (of the electro-dermal patch) is surrounded along the perimeterwith a closed cell foam to prevent water ingress to the hydrogel andadhesion reduction in a long shower and/or a 30 minute swim. In variousalternate embodiments, the EDP device 420 has an ingress protectionrating (IP) ranging from IP3 to IP5 and preferably a waterproof ratingof IP4 (that is, protection from water splashing from any direction for5 minutes) per IEC standard 60529. The electro-dermal patch device 420is composed of a flexible, rubber or silicone material with sufficientstructural strength to remain on the body once positioned while stillflexible enough to be peeled back by its edges. The electro-dermal patchdevice 420 is storable when not in use. In other embodiments, theelectro-dermal patch device 420 has an ingress protection rating (IPX)of at least IPX1, IPX2, IPX3, IPX4, IPX5, or IPX6, as known to personsof ordinary skill in the art.

Referring to FIG. 4C, in various embodiments, the bottom surface of theelectro-dermal patch device 420 includes at least one electrode 428having a specific configuration and able to provide enough electricalcurrent to stimulate dermatomes at various rates and pulses. In oneembodiment, the electro-dermal patch device 420 includes two electrodes428, 428′ having a pattern similar to that described with reference toFIG. 3B. In various embodiments, the electro-dermal patch device 420 isconfigured ergonomically to have as low a profile as possible anduniform in shape while still providing strong adhesive propertieslasting for at least four weeks during normal usage. In the embodimentdepicted in FIGS. 4B and 4C, the electro-dermal patch device 420includes no visible or tactile user interface and all communication withthe electro-dermal patch device 420 is achieved wirelessly using acompanion device as described further below.

In some embodiments, the electro-dermal patch device 420 includes adisposable battery which provides operating power for at least 90 daysof usage. In one embodiment, the electro-dermal patch device electroniccircuitry, in combination with the electrodes, is used to sense skinplacement and to turn therapy on and off automatically as furtherdescribed below. As described with reference to FIGS. 4B and 4C, theelectro-dermal patch device electronic core and adhesive pad withelectrodes are all combined in one flat component configured to providetherapy for at least 3 months. Alternatively, as described withreference to FIGS. 2A-2D and 4A, the electro-dermal patch deviceelectronic core is located within a housing separate from the pad and,in some embodiments, is easily replaceable by the patient or a medicalprofessional.

FIG. 4D is an oblique, top perspective view of an electro-dermal patchdevice 430, in accordance with another embodiment of the presentspecification. The electro-dermal patch 430 comprises a controllerassembly 431 and an electrode assembly 432. In one embodiment, thecontroller assembly 431 is reusable and detachable from a disposableelectrode assembly 432. It should be appreciated that while theelectrode assembly 432 touches the skin surface, the controller assembly431 remains above the skin surface. In some embodiments, the controllerassembly 431 remains within a range of 2 mm to 4 mm above the skinsurface, and preferably within 2 mm above the skin surface. In someembodiments, the EDP 430 has an elliptical or surfboard-like shape asseen in FIG. 4D. The surfboard shape allows for better adhesion to, andbetter movement with, a patient's skin surface. In an embodiment, theelliptical or surfboard-like shape of the EDP 430 has a short axis ordimension in a range of 0.1 to 0.6 inches, preferably around 0.33inches, and a long axis or dimension in a range of 2 to 8 inches,preferably around 5.365 inches, or any increment therein. In variousembodiments, the elliptical shape of the EDP 430 may require the user toorient the device in such a way that the short dimension of the EDPtraverses a smallest radius of the skin topography at a desired bodylocation.

FIG. 4E is an oblique, top perspective view of the controller assembly431 of the electro-dermal patch device of FIG. 4D. The controllerassembly 431 is flexible and comprises a flexible circuit with carrierand electrode contacts, discrete electrical components, a rechargeablebattery, and a flexible overmold 435. In a less preferred embodiment,the controller assembly comprises a rigid housing in place of theovermold. In some embodiments, the overmold 435 comprises a lowdurometer material with its geometry defined via a single shot injectionmold process wherein there is one durometer throughout the entireovermold 435.

In various embodiments, materials for the overmold 435 include athermoplastic elastomer, or (TPE), such as, for example, Monprenemanufactured by Teknor Apex as an ultra-soft TPE gel. TPEs are processedlike any other thermoplastic material but typically have low elasticmoduli, thus making the assembly flexible. In various embodiments, theTPE used as material for the overmold 435 has hardness in a range of 30to 70, preferably 45-65, and more preferably 50 to 60 on the sub-zeroshore (00) scale and a tensile modulus (indicative of flexuralproperties) in a range of 15 to 55 psi, preferably 30 to 45 psi. Forexample, Monprene Ultra Soft Gel grade CP-32053G (manufactured by TeknorApex) has a hardness measure of 53 on the subzero shore (00) scale and atensile modulus of about 37 psi. Viscosity of the Monprene Ultra SoftGel ranges from 30 to 65 on the subzero shore (00) scale. The EDP deviceof the present specification, taken as a whole, has a measurement on theflexural modulus scale per ASTM D-747 in a range of 10 psi to 35 psi,preferably 15 to 25 psi. Such overmolding material applies to all otherembodiments disclosed herein, whether in a single shot or dual shotmolding embodiment.

In other embodiments, thermoset material is used to create the overmold435 and facilitate the manufacture of the controller assembly 431because low durometer thermoset materials, such as liquid siliconerubber (LSR), have a low viscosity at room temperature prior to cure.This may make the filling of the injection mold cavity less stressful onthe flexible circuit during processing.

In some embodiments, the overmold 435 includes a plurality of slots 433.The slots 433 impart increased flexibility to the controller assembly431 and provide tooling access so that the flexible circuit within canbe accurately held in place during the overmolding process. The slots433 also act as windows to the flexible circuit within. In someembodiments, the controller assembly 431 further includes light emittingdiodes (LEDs) which, through the window-like slots 433, visuallycommunicate to the user product function and/or product status.

FIG. 4F is an oblique, bottom perspective view of the controllerassembly 431 of the electro-dermal patch device of FIG. 4D. Visible onthe underside of the controller assembly 431 is a flexible circuit 441with an edge of the overmold 435 around its periphery. In variousembodiments, the flexible circuit 441 provides three functions. One, theflexible circuit 441 contains and carries the discrete electricalcomponents and battery. Two, the flexible circuit provides electricalcontacts 439 used for connecting to a hydrogel of the electro-dermalpatch. Three, the flexible circuit provides a recharge path, if desired,for a rechargeable battery. In some embodiments, a flexible circuitcarrier 437 for the circuitry is comprised of a single or multilayerpolyimide/copper laminate processed by masking and etching of a coppersubstrate to create the circuit. In some embodiments, discretecomponents of the controller assembly 431 are either surface mounted or“thru hole” mounted comparable to the process used in the manufacture ofrigid printed circuit boards.

In various embodiments, the electrode contacts 439 are gold-platedcopper pads created as part of an etching and plating process of theflexible circuit 441. Flexible circuit 441 is comprised of a single ormultilayer polyimide/copper laminate where each layer of copper hascircuitry traces masked in such a way that when acid is applied, anyexposed copper is etched away leaving the masked areas in place.Subsequently, the masking material is removed with a solvent thusexposing the remaining copper creating the circuit. The electrodecontacts 439 are then gold plated to ensure connection to the hydrogelof the EDP. The creating of electrical contacts in this way has threeadvantages. One, it occurs at the processing stage and is embedded inthe cost of the flexible circuit 441 and therefore does not require anadditional process to handle and attach a discrete connector to both thecontroller assembly 431 and an electrode. Two, it eliminates the tighttolerances required of typical electrical connections. Three, it reducesthe cost of the electrode by not requiring the electrode to have aconnector at all since the electrical contacts on the controllerassembly 431 come in direct contact with a hydrogel of the electrodeassembly.

In another embodiment, as depicted in cross-sectional FIG. 4G, theelectro-dermal patch device (EDP) 490 includes a housing 491 and acapacitance type connection between the electrode contacts 439 and ahydrogel 436 of the electrode assembly, comprising a very thindielectric material 485 laminated over either the hydrogel 436 or theelectrode contacts 439. In various embodiments, a thickness of thedielectric laminate ranges from 0.001 inches for a single layer ofdielectric material, 0.003 inches of two layers of dielectric materialto no greater than 0.005 inches of three layers of dielectric material.The dielectric material 485 creates a DC blocking capacitor that is usedin an output stage circuit. There are three advantages to this alternateconnection. One, the exposed metal electrode contacts 439 on theunderside of the controller assembly would not need to be of anon-oxidizing type, such as gold, since they would not be reliant on anintimate conductor/conductor contact to maintain electrical connection.Two, circuitry impedance of a drive circuit would be much morepredictable since the connection to the hydrogel may not be a variableresistance upon subsequent usages. Three, the need of maintainingphysical contact (and electrical short) between the two metal contactsis eliminated, thus improving reliability/robustness of the connection.

FIG. 4H is an oblique, top perspective view of the controller assembly431 of the electro-dermal patch device of FIG. 4D with a portion of theovermold 435 cut away to expose additional components of the controllerassembly 431. In some embodiments, a flexible circuit 441 comprises aflexible circuit carrier 437 with a plurality of discrete components 445and at least one battery 447 surface mount soldered to exposed conductorpads. In some embodiments, a flexible circuit anchor 443 is laminated tothe perimeter of the flexible circuit carrier 437. In variousembodiments, the anchor 443 comprises a layer of polyimide or anothersemi-rigid material. Perforation holes 449 along the anchor 443perimeter length are included so that the overmold 435 material canaggressively attach to the flexible circuit 441, thus making arobust/reusable controller assembly 431. In various embodiments, thebattery 447 is that of a flat technology to which most batterychemistries conform. In some embodiments, the battery 447 isrechargeable. In various embodiments, the controller assembly 431 has atypical footprint area of 1.5 inches² for a physical aspect ratio of thewidth to the length of the flexible circuit carrier 437 of about 1:1.

FIG. 4I is an oblique, top perspective view of the electrode assembly432 of the electro-dermal patch device of FIG. 4D. In variousembodiments, the electrode assembly 432 is flexible and comprises ahydrogel 436, hydrogel carrier 438, release liner 442, and electrodebezel 434. The electrode contact surface is below the hydrogel 436surface and therefore not shown. The electrode surface is in physicalcontact, and in electrical communication with, the hydrogel 436 which iscontained in a polymer coating (carrier). The electrode bezel 434 isdesigned to keep the carrier 438 and hydrogel 436 in place. A releaseliner 442 is on the base of the carrier 438 surface and serves toprotect the adhesive coating of the carrier 438 surface until a user isready to use the EDP. At that point, the release liner 442 is removedand the carrier 438 and adhesive are exposed.

Once the EDP is fully assembled, the electrode contacts 439 depicted inFIG. 4F are in physical contact with the hydrogel 436 depicted in FIG.4I to allow for transmission of electrical stimuli from the EDP to theskin surface of a patient. The hydrogel carrier 438 and release liner442 allow for simple separation of the controller assembly from theelectrode assembly 432 so that a reusable controller assembly can bejoined with a new electrode assembly.

FIG. 4J is an oblique, bottom perspective view of the electro-dermalpatch device 430 of FIG. 4D. Visible are the overmold 433 and flexiblecircuit carrier 437 of the controller assembly and the hydrogel 436,hydrogel carrier 438, and electrode bezel 434 of the electrode assembly.

FIG. 4K is a side perspective view of the electro-dermal patch device430 of FIG. 4D. In various embodiments, the EDP 430 has a thickness, orheight h from a patient's skin surface, in a range of 0.075 to 0.25inches. In one embodiment, the EDP 430 has a thickness, or height h froma patient's skin surface of 0.156 inches.

FIGS. 4L and 4M are oblique, top perspective, short axis and frontperspective, cross-sectional views respectively, of the electro-dermalpatch device 430 of FIG. 4D. Visible are the overmold 435, discretecomponent 445, battery 447, flexible circuit carrier 437, and circuitcarrier anchor 443 of the controller assembly 431 and the hydrogel 436,hydrogel carrier 438, and electrode bezel 434 of the electrode assembly432. The controller assembly 431 is configured to detachably connect tothe electrode assembly 432 such that the overmold 435 sits within anarea defined by the electrode bezel 434 and the electrode contacts (439in FIG. 4F) are in physical contact with the hydrogel 436. Using apatient's skin surface as a point of reference, the overmold 435 of thecontroller assembly 431 and the electrode bezel 434 of the electrodeassembly 432 comprise a distal or outer surface 430 d of the EDP 430.The hydrogel 436 comprises a proximal or inner, skin facing surface 430p of the EDP. The discrete component 445, battery 447, flexible circuitcarrier 437, and circuit carrier anchor 443 are positioned within thecontroller assembly 431 in a central portion of the EDP 430. Thehydrogel carrier 438 is positioned between the electrode bezel 434 andhydrogel 436 of the electrode assembly 432 about a periphery of the EDP430.

FIGS. 4N and 4O are oblique, top perspective, long axis and sideperspective, cross-sectional views respectively, of the electro-dermalpatch device 430 of FIG. 4D. Visible are the overmold 435, discretecomponent 445, battery 447, flexible circuit carrier 437, circuitcarrier anchor 443, and slots 433 of the controller assembly 431 and thehydrogel 436 (seen in FIG. 4O), hydrogel carrier 438, and electrodebezel 434 of the electrode assembly 432.

In accordance with various embodiments, the electrodes, such as theelectrode contacts 439 of FIG. 4F, are disposed or printed on the lowersurface of the pads of the EDP device 430 of FIG. 4D in the form of aplurality of patterns or geometries. FIGS. 4P through 4S illustrate,respectively, a first pattern 450, a second pattern 455, a third pattern460 and a fourth pattern 465 of corresponding first 451, 452, second456, 457, third 461, 462 and fourth electrodes 466, 467. In embodiments,a distance between the electrode, such as electrodes 439 of FIG. 4F orelectrodes of first, second, third and fourth electrode patterns ofFIGS. 4P through 4S, is less than 20 mm, preferably less than 15 mm,preferably less than 10 mm, preferably less than 5 mm. In oneembodiment, the distance between the electrodes is about 4 mm.

Referring to FIG. 4P, in one embodiment, the electrodes 451, 452 eachhave an approximate ‘sine wave’ pattern 450 and extend along a long axis480 of a substantially elliptical pad 475, for example. The pattern 450comprises a plurality of peaks 453, 453′ and valleys 454, 454′. In oneembodiment, the peaks 453 of a first electrode 451 are wider than thepeaks 453′ of a second electrode 452 such that the peaks 453′ of thesecond electrode 452 fit within the peaks 453 of the first electrode451. Referring to FIG. 4Q, in another embodiment, the electrodes 456,457 each have an approximate ‘sine wave’ pattern 455 also extendingalong the long axis 480 of the pad 476. The ‘sine wave’ pattern 455differs from the pattern 450 of FIG. 4P in that the pattern 455 has alonger ‘period’ (wherein ‘period’ is a distance between consecutivepeaks and valleys measured along the long axis 480) relative to thepattern 450. As a result, the pattern 455 comprises a plurality of peaks458, 458′ and valleys 459, 459′ that are fewer in number relative to thenumber of peaks 453, 453′ and valleys 454, 454′ of pattern 450.

Referring now to FIG. 4R, in one embodiment, the electrodes 461, 462each have a linear pattern 460 and extend along the long axis 480 of thepad 477. In accordance with an embodiment, a gap 464 between theelectrodes 461, 462 is maintained or remains constant along the longaxis 480. Referring to FIG. 4S, in one embodiment, the electrodes 466,467 each have a linear pattern 465 and extend along a short axis 481 ofthe pad 478, wherein the axes 480, 481 are substantially perpendicularto each other. In accordance with an embodiment, a gap 468 between theelectrodes 466, 467 is maintained or remains constant along the shortaxis 481.

FIG. 5A is an oblique, top perspective view of an electro-dermal patchdevice 500 in accordance with another embodiment of the presentspecification. The EDP device 500 is overmolded and configured in around, circular or “sand dollar” like shape. The overmold 515 includes afirst overmold portion 505 forming a perimeter of the EDP device 500 anda second overmold portion 510 forming a central portion of the EDPdevice 500. While described in reference to the “sand dollar”configuration depicted in FIG. 5A, a “two-shot” overmold process(comprising first and second overmold portions) is not specific to thesand dollar shape and can be applied to create any shape of EDP. FIG. 5Bis a side perspective view of the EDP device 500 showing hydrogel pads520. The hydrogel pads 520, that in some embodiments are concentric ringshaped, are also shown in FIG. 5C which is a bottom view of the EDPdevice 500. As shown in FIG. 5B, the overmold 515, comprising the firstand second overmold portions 505, 510, envelopes the full surface areaor footprint of the hydrogel pads 520, in accordance with an aspect ofthe present specification.

FIG. 5D is an oblique, top perspective view of the EDP device 500 with aportion of the overmold 515 (of FIG. 5A) removed to reveal internalcomponents of the EDP device. FIG. 5E is a side cross-sectional viewwhile FIG. 5F is a top perspective view of the EDP device 500 with theentire overmold 515 (of FIG. 5A) removed.

Referring now to FIGS. 5D through 5F, the first and second overmoldportions 505, 510 encompass a flexible circuit carrier 525 supporting ahousing 530 that includes a flexible circuit having a plurality ofdiscrete electronic components (such as those described with referenceto FIG. 1A) including a rechargeable battery. The housing 530 is inelectrical communication with electrode contacts 535 that are inphysical contact with the hydrogel pads 520. It should be appreciatedthat while the electrode contacts 535 in physical contact with thehydrogel pads 520 touch the skin surface, the housing 530 remains abovethe skin surface. In some embodiments, the housing 530 remains within arange of 2 to 4 mm above the skin surface, and preferably within 2 mmabove the skin surface. In some embodiments, a flexible circuit anchor540 is laminated to the perimeter of the electrode contacts 535. Invarious embodiments, the anchor 540 comprises a layer of polyimide oranother semi-rigid material. Perforation holes 542 along the anchor 540perimeter length are included so that the material of the overmoldportions 505, 510 can seep therein and attach thereto to fully envelopethe electrode contacts 535 as well as the hydrogel pads 520. Since theovermold portions 505, 510 together envelop the hydrogel pads 520, thisallows for the flexible circuit to provide electrical contacts forconnecting to the hydrogel thus keeping the cost of the hydrogel basedelectrodes low by eliminating the need for tight tolerance discreteelectrical connectors.

Referring back to FIG. 5A, in some embodiments, the overmold portions505, 510 comprise low durometer materials with their geometry definedvia a two shot injection mold process. In various embodiments, materialsfor the overmold 505, 510 include a thermoplastic elastomer (TPE) suchas, for example, Monprene (manufactured by Teknor Apex) as an ultra-softTPE gel. TPEs are processed like any other thermoplastic material buttypically have low elastic moduli, thus making the assembly flexible. Afirst shot injection mold forms the overmold portion 505 as a narrowcross-sectional hoop or perimeter of the EDP device 500 while a secondshot injection mold forms the overmold portion 510.

In various embodiments, the TPE used as material for the overmoldportions 505, 510 has hardness in a range of 30 to 70, preferably 45-65,and more preferably 50 to 60 on the sub-zero shore (00) scale and atensile modulus (indicative of flexural properties) in a range of 15 to55 psi, preferably 30 to 45 psi. For example, Monprene Ultra Soft Gelgrade CP-32053G (manufactured by Teknor Apex) has a hardness measure of53 on the subzero shore (00) scale and a tensile modulus of about 37psi. Viscosity of the Monprene Ultra Soft Gel ranges from 30 to 65 onthe subzero shore (00) scale. It should be appreciated that the use oflow durometer materials, such as Monprene gel, along with the built-inflex joints of the flexible circuit enable the EDP device assembly to bequite supple and achieve a measurement on the flexural modulus scale perASTM D-747 in a range of 10 psi to 35 psi, preferably 15 to 25 psi.

In accordance with aspects of the present specification, the flex jointsexist between rigid or inflexible inseparable assemblies within the EDPdevice. In one embodiment, the battery and the flexible circuit areinseparable assemblies. Therefore, a flexible joint exists between thesetwo assemblies. In various embodiments, flex joints between rigidinseparable assemblies are obtained by designing both first shot andsecond shot tooling (for the two shot injection molding process) suchthat in the fully fabricated EDP device, soft overmold material residesbetween the rigid assemblies. Also, the joints are oriented within thebody of the EDP device, such that when the EDP device is placed on thepatient's body, in a way that will properly stimulate the intendeddermatomes, the flex joints are perpendicular to the curved contour ofthe patient's body at that location, thereby enabling flexing of the EDPdevice to conform to the patient's body curvature.

In one embodiment, the overmold portion 505 utilizes a higher durometerTPE compared to the overmold portion 510. The overmold 505 is of aslightly higher durometer material (than of the overmold portion 510)since although the perimeter of the device needs to be flexible it alsoneeds to provide tensile integrity such that induced stretching viarough handling of the EDP will not result in damage to the encompassedelectronic circuitry. The higher durometer material which is used tocreate the narrow cross sectional hoop 505 along the perimeter is amodified TPE manufactured by Kraton Corporation, grade G-7970, inaccordance with an embodiment. This TPE grade is a block polymer inwhich the elastomeric portion of the molecule is a saturated olefinpolymer. The higher durometer material ranges from 35 to 45 Shore A, invarious embodiments, with the lower durometer material being below 35Shore A.

In various embodiments, the electro-dermal patch device 500 has aningress protection rating (IPX) of at least IPX7, allowing the patientto take showers and swim for at least 30 minutes while theelectro-dermal patch device 500 is positioned on the body without waterdamage to the electro-dermal patch device 500. In various alternateembodiments, the EDP device 500 has an ingress protection rating (IP)ranging from IP3 to IP5 and preferably a waterproof rating of IP4 (thatis, protection from water splashing from any direction for 5 minutes)per IEC standard 60529.

In various embodiments, the flexible overmold, such as the overmold 435of FIG. 4E and the overmold 515 of FIG. 5A, is also non-toxic tosafeguard against any incidental contact with the skin.

In various embodiments, the housing 530 has a typical footprint area of1.5 inches² for a physical aspect ratio of the width to the length ofthe flexible circuit carrier 525 of about 1:1.

In one embodiment, the electro-dermal patch device (EDP) comprises aprint-on-the-skin circuit designed to be printed directly onto theepidermis of a patient. The printable EDP comprises film electrodeshaving a thickness sufficient to withstand the currents required for theelectrical stimulation protocols of the current specification withoutdegrading. The printable EDP comprises a wireless transceiver (forcommunication with a companion device), microcontroller, powermanagement module or battery, pulse generator, and at least oneelectrode. In some embodiments, the printable EDP further includes atleast one sensor.

In another embodiment, the electro-dermal patch device (EDP) comprises ahighly flexible membrane, or ‘flex-circuit’, configured to adhere to thepatient's epidermis. The ‘flex-circuit’ is configured to be applied andadhere to the patient's skin much like a conventional tattoo. The‘flex-circuit’ comprises a curved, or ‘S’ shaped circuit. The curvedshape allows the ‘flex-circuit’ to move with the patient's skin withoutbeing damaged. The ‘flex-circuit’ EDP comprises a wireless transceiver(for communication with a companion device), microcontroller, powermanagement module or battery, pulse generator, and at least oneelectrode. In some embodiments, the ‘flex-circuit’ EDP further includesat least one sensor.

In yet another embodiment, the electro-dermal patch device (EDP)comprises a combination of a printed circuit board, for example gradeFR-4, and a flex circuit, for example Kapton®, with a connector.

In various embodiments, the dimensions and/or form factor of theelectro-dermal patch device of the present specification has any one ora combination of the following attributes: at least one dimension oflength or width measuring less than 1.26 inches; a volume in a range of0.1 inches³ to 0.5 inches³; a weight in a range of 10 grams to 80 grams;a physical aspect ratio of width to thickness in a range of 1:1 to 6:1;a maximum height or thickness of the EDP of 1 inch, preferably less than¾ inch, and more preferably, ½ inch or less; a footprint of the EDPdevice in a range of 3.5 inches² (1:1 aspect ratio) to 6 inches² (6:1aspect ratio); an electrical aspect ratio in a range of 1:1 to 1.5:1. Invarious embodiments, a ratio of EDP electrode surface area to EDP weightis selected to keep the size of the electrode equal to or smaller thanthe skin contacting foot print of the EDP device. In some embodiments,the ratio of EDP electrode surface area to EDP weight is in a range of0.1 to 0.8 square inches per gram weight of the EDP device, preferablybetween 0.2 and 0.5 in²/gram.

In some embodiments, a substantially rectangular shaped EDP (such asthat of FIGS. 4B, 4C) has a width of 1.25 inches, a length of 4.0 inchesand a height of 0.15 inches. In some embodiments, a circular shaped EDP(such as that of FIGS. 5A through 5F) has a radius of 1.125 inches and aheight of 0.15 inches.

It should be appreciated that, while different physical configurationsmay exist for the electrical dermal patch, it is important that thedevice deliver enough electrical stimulation in a reasonably sized patchstructure, namely one that is not so large that it would beuncomfortable to wear. To that end, in one embodiment, a preferredelectrical dermal patch comprises an electrode that is removablyattached to the surface of the housing. The contact surface area of suchelectrode is preferably less than 10 in², more preferably less than 8in², and still preferably 7 in² or less and within a range of 0.1 in² to10 in², or, more preferably, 0.5 in² to 4 in² and the programmablecurrent ranges from 100 μA to 500 mA, or, more preferably, 2 mA to 50mA. In these embodiments, the current density of the electrical dermalpatch is in a range of 10 μA/in² to 5000 mA/in², more preferably 25μA/in² to 1000 mA/in², and even more preferably 0.5 mA/in² to 100mA/in². The total contact surface area of the electrical dermal patch inthis configuration is equal to the contact surface area of itselectrode(s).

In another embodiment, a preferred electrical dermal patch comprises anelectrode that is at least partially affixed within the housing and notremovably attached to a surface of the housing. The contact surface areaof such electrode is preferably less than 10 in², more preferably lessthan 8 in², and still preferably 7 in² or less and within a range of 0.1in² to 10 in², or, more preferably, 0.5 in² to 4 in² and theprogrammable current ranges from 100 μA to 500 mA, or, more preferably,2 mA to 50 mA. In these embodiments, the current density of theelectrical dermal patch is in a range of 10 μA/in² to 5000 mA/in², morepreferably 25 μA/in² to 1000 mA/in², and even more preferably 0.5 mA/in²to 100 mA/in². The total contact surface area of the electrical dermalpatch in this configuration is equal to the contact surface area of itselectrode(s) plus a small additional amount for peripheral portions ofthe housing, which typically will not amount to more than an additional5-10% more contact surface area relative to the electrode(s) surfacearea.

It should be appreciated that, in either configuration, one, two, threeor more electrodes may be attached to the housing, or integrated intothe housing, each having the characteristics described above, withoutdeparting from the scope of this invention.

FIGS. 55A and 55B are top perspective views while FIG. 55C is a bottomview of an electro-dermal patch device 5510, in accordance with anembodiment, having a pair of removable and replaceable conductivehydrogel, hydrocolloidal or foam pads 5520 (FIG. 55C) and asubstantially rectangular shaped patch housing 5535. In an embodiment,the housing approximates an oval shape or a curvilinear rectangle. Thepatch housing 5535 includes a microcontroller, pulse generator, wirelesstransceiver, and power management module, such as those described withreference to FIG. 1A. The electrodes extend from the housing 5535 andinto the pads 5520 for placement proximate the skin surface of apatient. It should be appreciated that while the electrode pads 5520touch the skin surface, the housing 5535 remains above the skin surface.In some embodiments, the housing 5535 remains within a range of 2 mm to4 mm, and preferably within 2 mm above the skin surface. In oneembodiment, the pads 5520 have two electrodes 5518 disposed or printedon a lower surface 5522 of the pads 5520. The lower surface 5522 isadhesive—covered by a tab—such that, when the tab is removed the basesurface 5522 can be adhered to the skin. The peel strength of theadhesively adhered pads 5520 is in a range of 1.0 to 2.1 Newton,allowing the device to be adhered to the skin for at least 8 hours ofintensive activity, such as exercise. The pads 5520, when adhered to auser's skin, enable the electrodes to be in direct contact with theouter surface of the skin. As illustrated in FIG. 55C, in embodiments,pads 5520 have each of the two electrodes 5518 disposed or printed inopposing halves of the lower surface 5522. In embodiments, a distance‘D’ between the two electrodes 5518 is less than 20 mm, preferably lessthan 15 mm, preferably less than 10 mm, preferably less than 5 mm. Inone embodiment, the distance ‘D’ between the two electrodes is about 4mm. In an embodiment, each of the printed electrodes 5518 has a surfacearea in a range of 0.01 in² to 10 in², preferably 1.7 in² that isdivided by a depression or spine 5503 having a width ‘W’ in a range of 1to 12 mm, preferably 6 mm. In some embodiments, the total surface areataken up by the base of the two electrodes 5518 is preferably less than10 in², more preferably less than 8 in², and still preferably 7 in² orless or within a range of 0.1 in² to 10 in². In accordance with someembodiments, the skin contact surface area of each one of the twoelectrodes 5518 is 3 cm²±0.5 cm², the distance ‘D’ is about 0.2 cm±0.1cm and an area between the two electrodes is 0.2 cm²±0.1 cm² andpreferably in a range of 0.05 cm² to 0.4 cm². In accordance with someembodiments, the total skin contact surface area of the two electrodes5518 is in a range of 2 cm² to 4 cm².

In accordance with an embodiment, the housing 5535 includes a firstportion 5525 forming a perimeter or outer border of the EDP device 5510and a second portion 5530 forming a central portion of the EDP device5510. In various embodiments, the system electronics described withreference to FIG. 1A are enclosed substantially within the secondportion 5530. In some embodiments, the top surface 5512 of the secondportion 5530 includes a button 5513 that can be actuated, such as bypressing or switching, to enable the EDP device 5510 to be toggledbetween an activated or deactivated state and/or to provide feedback tothe patient when pressed while the EDP device 5510 is in activatedstate. In some embodiments, button 5513 may provide differentfunctionality depending on the number of times the button is pressed ordepending upon the position of the switch. For example, with the EDPdevice 5510 in activated state and adhered to the patient's skin,pressing or switch button 5513 may provide a tactile feedback, such as avibratory or audio feedback, indicating tissue and electrode contactintegrity and electrode integrity.

In an embodiment, an overall length of the EDP device 5510 along alongitudinal axis 5501 is less than 200 mm, preferably less than 100 mm,preferably approximately 76 mm, while an overall width along an axis5502 (wherein axis 5502 is substantially perpendicular to thelongitudinal axis 5501) is less than 200 mm, preferably less than 100mm, preferably less than 50 mm, and preferably approximately 46 mm. Inan embodiment, a width of the second portion 5530 along the axis 5502 is32 mm to allow for a 7 mm thickness of the first portion 5525 that formsthe perimeter or outer border of the EDP device 5510. In one embodiment,the button 5513 has a first dimension of 11 mm along the longitudinalaxis 5501 and a second dimension of 16 mm along the axis 5502.

In some embodiments, visual feedback may additionally or alternativelybe generated via LEDs in accordance with various configurations. Also,in some embodiments, instead of a separate button 5513 the entire topsurface 5512 is configured to function as an actuatable button. In oneembodiment, FIG. 55H shows an EDP device 5510 h with button 5513 and avisual indicator 5540, comprising at least one LED, positioned on thetop surface 5512 of the second portion 5530. In another embodiment, FIG.55I shows an EDP device 5510 i having the first portion 5525 surroundingthe perimeter of the central second portion 5530. In this embodiment,button 5513 is positioned on the top surface 5512 of the second portion5530 while the visual indicator 5540 comprises a perimeter or rim of thebutton 5513 which is visually lit using at least one LED enclosed withinthe second portion 5530. In yet another embodiment, FIG. 55J shows anEDP device 5510 j having the first portion 5525 surrounding theperimeter of the central second portion 5530. In this embodiment, theentire top surface 5512 of the second portion is configured to functionas an actuatable button 5513. Visual indicators 5540, comprising one ormore LEDs, are also positioned on the top surface 5512. It should beappreciated that the visual indicator 5540 of the embodiments of FIGS.55H, 55I and 55J generate visual feedback such as, but not limited to, ared light indicating that the patient's health parameter such as thewill power levels, scores, reserves or conservation is very low (at orbelow a predefined minimum will power threshold), a yellow lightindicating that the patient's will power reserve is in a medium zone,and a green light indicating that the patient's will power reserve isrobust or high (above a predefined will power threshold). Instead ofwill power, the visual indicator 5540 can be used to generate feedbackcorresponding to any health parameter such as, but not limited to,target weight, dietary compliance, hunger level, exercise or activitylevel. Additionally, the visual indicator 5540 may also be used toindicate the active or inactive state of the EDP device in lieu of or inaddition to the feedback generated through the button 5513. Stillfurther, the visual indicator may be used to communicate a battery levelof the EDP.

Referring back to FIGS. 55A through 55C, in various embodiments thehydrogel pads 5520 are replaceable, enabling attachment of newconductive pads and therefore new adhesion surfaces to the EDP device5510. FIG. 55D is a bottom perspective view of the EDP device 5510 withthe hydrogel pads removed. Two electrode contacts 5519 in electricalcommunication with the housing 5535 (FIG. 55A, B) are visible on thebottom surface 5542, of the second portion 5530. In accordance with anaspect, a ridge or rim portion 5545, around the circumference, perimeteror outer border 5543 of the bottom surface 5542 of the first portion5525 (FIG. 55A, B), forms a nest, recess or hollow to enable thehydrogel electrode pads 5520 (FIG. 55C) to be snapped therein such thatthey are flush with ridge or rim portion 5545. This allows theelectrodes to be less noticeable while enabling patients to easily matchelectrode or hydrogel pads to the EDP device via snaps or pinconfigurations corresponding to the electrode contacts 5519. In anembodiment, the ridge or rim portion 5545 has a thickness of 2 mm. FIG.55E is a side perspective view of the EDP device 5510 with the hydrogelpads 5520 tucked in or snapped into place within the nest formed by thefirst portion 5525 at the bottom of the EDP device 5510.

In accordance with an aspect, in some embodiments the electrode pads5520 (FIG. 55C) include two types of skin contacting adhesives (incontrast to electrode pads 5520 which use only hydrogel as an adhesive)which cause the electrodes to be substantially waterproof. FIG. 55Kshows a bottom view of a waterproof electrode pad assembly 5565 whileFIG. 55L shows a disassembled, breakaway view of the electrode pad 5565.As shown in FIG. 55K, a bottom surface 5566 of the electrode pad 5565has a first skin contacting adhesive 5567 and a second skin contactingadhesive 5568 along the periphery of the bottom surface 5566 of the padas well as along a mid-rib 5569 (that is, between the two electrodes5518 shown in FIG. 55C) forming first skin contacting adhesive areas5567 a, 5567 b. In various embodiments, the first skin contactingadhesive 5567 is hydrogel which is used as a primary adhesive to theskin as well as a conductive medium through which electric current flowsfrom the EDP device to the patient's skin. The second skin contacting(secondary) adhesive 5568 is an acrylic-based pressure sensitiveadhesive that uses an adhesive coated non-woven polyester fabric (suchas Hypafix manufactured by Smith and Nephew) or adhesive-coatedpolyethylene acrylic foam (such as MDFT4532 manufactured by Coating andConverting Technologies). Electrode pads 5565 can be peeled off the EDPdevice by pulling on a removal tab 5570.

Referring now to FIG. 55L, the electrode pad assembly 5565 comprises apair of snaps 5571 at the top followed by a thermoplastic polymer or PET(Polyethylene Terephthalate) layer 5572, a double-sided tape layer 5573,a carbon loaded vinyl layer 5574, snap eyelets 5575, first skincontacting adhesive or hydrogel 5567 and second skin contacting acrylicbased adhesive 5568.

The acrylic adhesive 5568 is not soluble in water thus making itimpervious to water. The hydrogel 5567 is not impervious to water. Whenthe hydrogel 5567 comes in contact with water (human sweat or a shower),it absorbs the water and becomes less adherent to the skin while stillremaining electrically conductive. With the use of the secondary acrylicadhesive 5568 adhesion to the skin remains unchanged in the presence ofwater. The use of secondary adhesive 5568 allows the user to keep theelectrode pad assembly 5565 as well as the EDP device on their skinduring strenuous activity where the user might sweat or shower and, as aresult, reduce adherence of the primary adhesive or hydrogel 5567.

FIG. 55M is a disassembled or exploded view of electrode pad assemblyemploying either a foam pad with acrylic adhesive or a hydrocolloidadhesive. Referring now to FIG. 55M, the electrode pad assembly 5585comprises a pair of snaps or romefast studs 5586 at the top following bea thermoplastic polymer or PET (Polyethylene Terephthalate) layer 5587,a double-sided tape layer 5588, a first adhesive layer 5589, a carbonloaded vinyl layer 5590, snap or romefast eyelets 5591, and a secondskin contacting adhesive or hydrogel layer 5592.

In some embodiments, PET layer 5587 has a thickness or 0.005 inches.

In some embodiments, first adhesive layer 5589 is comprised of a foamwith acrylic adhesive. In some embodiments, first adhesive layer 5589 is0.032 inches thick. In embodiments where first adhesive layer 5589 is afoam, acrylic layer, second adhesive or hydrogel layer 5592 is 0.032inches thick.

In some embodiments, first adhesive layer 5589 is comprised of ahydrocolloid adhesive. In embodiments where first adhesive layer 5589 isa hydrocolloid adhesive layer, second adhesive or hydrogel layer is0.020 inches thick. In an embodiment, the surface area of thehydrocolloid layer is a maximum of 8 in². In embodiments, thehydrocolloid adhesive is designed such that it is waterproof andsweatproof and will stay on during intensive exercise. In embodiments,the hydrocolloid adhesive is designed to adhere to the skin for a timeperiod ranging from at least 8 hours to several days.

FIGS. 55F and 55G are side perspective views with a portion of thehousing 5535 cut away to expose an assembly of the EDP device 5510, inaccordance with an embodiment also showing how each portion of thehousing is connected. Referring now to FIGS. 55F, 55G, in accordancewith an aspect, the central second portion 5530 is manufactured as aclamshell comprising a first top or upper part 5531 and a second bottomor lower part 5532 that define a space 5555 therebetween to house oraccommodate the system electronics described with respect to FIG. 1A.The first portion 5525 is manufactured with a flange, collar or rib 5550that runs along the inner circumference of the first portion 5525.Similarly, the first part 5531 also has a flange, collar or rib 5560extending vertically downwards and running along the inner circumferenceof the first part 5531. During assembly, the flange 5550 is sandwichedbetween and used to connect the first and second parts 5531, 5532 of theclamshell-like central second portion 5530. In various embodiments, theflange 5550 is L-shaped that locks with the vertically extending flange5560 to enable retention of the first portion 5525 by the second portion5530 and form the assembly of the EDP device 5510. Also visible is theridge or rim portion 5545 that defines the nest therebetween toaccommodate the hydrogel pads 5520 (or the waterproof electrode pads5565 of FIGS. 55K, 55L in some embodiments).

The EDP device assembly formed by connecting the first portion 5525 bythe clamshell-like second portion 5530 has a plurality of advantages,such as but not limited to: simplicity of assembling the EDP device;reliable fit of the first and second portions 5525 and 5530; ease ofaccommodating one or more LEDs within the space 5555 to generate lightaround the rim of the button 5513 (as shown in FIG. 55I), which, in someembodiments, is the entire top surface 5512 (as shown in FIG. 55J);enabling a plurality of different colored first portions or skirts 5525to be easily changed and reassembled with the second portion 5530;allowing internal components within the space 5555 (comprising systemelectronics of FIG. 1A, for example) to be recycled or replaced; andeffectively protecting the internal components from damage.

Referring back to FIGS. 55A, 55B and 55F, in some embodiments thecentral second portion 5530 is made of hard plastic while the firstskirt-like portion 5525 is made from relatively more flexible and softmaterials such as silicone, rubber, LSR (Liquid Silicone Rubber) or anyother flexible polymer known to persons of ordinary skill in the art. Inother embodiments, materials for both the first as well as the secondportions 5525, 5530 comprise silicone, rubber or LSR of similar ordifferent durometer ratings. In one embodiment, material for the firstportion 5525 is a low durometer silicone while material for the secondportion 5530 is a relatively high durometer silicone. In someembodiments, materials for the housing 5535 include a thermoplasticelastomer, or (TPE), such as, for example, Monprene manufactured byTeknor Apex as an ultra-soft TPE gel. TPEs are processed like any otherthermoplastic material but typically have low elastic moduli, thusmaking the assembly flexible. In various embodiments, the TPE used asmaterial for the housing 5535 has hardness in a range of 30 to 70,preferably 45-65, and more preferably 50 to 60 on the sub-zero shore(00) scale and a tensile modulus (indicative of flexural properties) ina range of 15 to 55 psi, preferably 30 to 45 psi. For example, MonpreneUltra Soft Gel grade CP-32053G (manufactured by Teknor Apex) has ahardness measure of 53 on the subzero shore (00) scale and a tensilemodulus of about 37 psi. Viscosity of the Monprene Ultra Soft Gel rangesfrom 30 to 65 on the subzero shore (00) scale. The EDP device of thepresent specification, taken as a whole, has a measurement on theflexural modulus scale per ASTM D-747 in a range of 10 psi to 35 psi,preferably 15 to 25 psi.

In various embodiments, the dimensions and/or form factor of theelectro-dermal patch device 5510 has any one or a combination of thefollowing attributes: at least one dimension of length or widthmeasuring less than 1.26 inches; a volume in a range of 0.1 inches³ to0.5 inches³; a weight in a range of 10 grams to 80 grams; a physicalaspect ratio of width to thickness in a range of 1:1 to 6:1; a height hof less than 1 inch, preferably less than ¾ inch, and more preferably, ½inch or less; a footprint of the EDP device in a range of 3.5 inches²(1:1 aspect ratio) to 6 inches² (6:1 aspect ratio); an electrical aspectratio in a range of 1:1 to 1.5:1. In various embodiments, a ratio of EDPelectrode surface area to EDP weight is selected to keep the size of theelectrode equal to or smaller than the skin contacting foot print of theEDP device. In some embodiments, the ratio of EDP electrode surface areato EDP weight is in a range of 0.1 to 0.8 square inches per gram weightof the EDP device, preferably between 0.2 and 0.5 in²/gram.

Companion Device/Control

Referring back to FIG. 1A, the electro-dermal patch device 110 is indata communication with and controlled by the companion device 105 inaccordance with an aspect of the present specification. The companiondevice 105 is further capable of being in data communication with aremote patient care facility and/or patient care personnel. Thecompanion device 105 is in data communication with the electro-dermalpatch device 110 through a direct link to drive therapy. In accordancewith a preferred embodiment, the companion device 105 is a hand-heldcomputing device such as a watch, wristband, smartphone, tablet, or PDAthat controls the electro-dermal patch device 110 through a wirelessconnection, such as Bluetooth, WiFi or any other private/public cellularor TCP/IP network such as the Internet. In some embodiments, thecompanion device is physically separated from and external to the EDP,hence referred to as a separate or external device. In some embodiments,the companion device may be a wearable activity monitor that tracksheart rates, movement, and other physiological data. In someembodiments, the EDP may be integrated into a wearable activity monitorand communicate with an external device, such as a smartphone, that isexecuting a software application in data communication with the wearableactivity monitor.

In embodiments the companion device 105 may be in data communication,simultaneously, with the EDP device as well as other devices orequipment. For example, the companion device 105 configured as asmartphone may be in data communication with a car or a car audio systemwhile also being in communication with at least one EDP device.Accordingly, when in the user is in the car, the car functions as themaster while the smartphone (companion device) functions as the slavewhereas between the smartphone and the EDP device, the smartphone is themaster and the EDP is the slave.

The companion device 105 is configured to monitor and record (‘learn’) apatient's appetite patterns and monitor and record, learn, and modifythe stimulation parameters of the stimulation protocols delivered by theelectro-dermal patch device 110. In some embodiments, all therapyprovided by the electro-dermal patch device 110 is coupled withrecording (keeping a log of the therapy) and patient compliancereminders provided by the companion device 105. FIG. 6A shows theelectro-dermal patch device 610 of the present specification, configuredas a skin patch and placed at a lateral thoracic dermatome, inaccordance with an embodiment, and being wirelessly controlled by asmartphone 605, for example.

With reference to FIG. 1A, in accordance with an aspect, the companiondevice 105, which is a hand-held computing device (such as a smartphone,tablet, PDA) in various embodiments, runs or implements a HealthManagement software application. The Health Management applicationactivates, deactivates and controls the electro-dermal patch device 110to provide a plurality of stimulation therapies or protocols inaccordance with various embodiments. In some embodiments, this isenabled by pairing or syncing the hand-held computing device (wirelesslyor through a wired connection) with the electro-dermal patch device 110.In some embodiments, the Health Management application pairs or syncsand controls more than one electro-dermal patch device 110 worn by theuser for treating a combination of conditions.

In still further embodiments, the Health Management application iscapable of also communicating (via pairing or syncing) with a thirdparty device (including a third party application software on anexternal device), with physiological sensors, configured to be worn onthe human body, such as around the wrist, in order to monitor, acquire,record, and/or transmit the physiological data, to receive and integrateexercise and weight loss information, along with one or moreelectro-dermal patch devices 110 of the present specification. Invarious embodiments, the third party device includes a glucose sensor.

In embodiments where the Health Management application pairs or syncswith a plurality of electro-dermal patch devices 110 it is desired thatthe user be able to ascertain that the Health Management application hassuccessfully paired or synced with each of the plurality ofelectro-dermal patch devices. In some embodiments, an electro-dermalpatch device and the companion device (running the Health Managementapplication) flash a similar color (using LEDs) to indicate successfulpairing or syncing. Thus, each of the plurality of electro-dermal patchdevices flash a color in tandem with the companion device, one afteranother for example or simultaneously, indicating successful pairing orsyncing with each of the electro-dermal patch device. In someembodiments, the companion device (running the Health Managementapplication) displays a unique identification (ID) of an electro-dermalpatch device indicating successful pairing or syncing with theelectro-dermal patch device. Thus, the unique IDs of each of theplurality of electro-dermal patch devices are displayed by the companiondevice indicating successful pairing or syncing with each of theelectro-dermal patch device.

In accordance with an aspect of the present specification, cervicalauscultation is used to detect pharyngeal swallow and thereforedetermine if the user is indulging in an eating activity. FIG. 56illustrates a swallow detection device 5605 configured to be worn by auser around her neck, in accordance with some embodiments. The HealthManagement application is capable of also communicating (via pairing orsyncing) with the swallow detection device 5605 in order to monitor,acquire, record, and analyze swallowing sounds while the user is engagedin eating. In an embodiment, the swallow detection device 5605 comprisesan accelerometer to detect signals associated with swallowing sounds andnoise associated with laryngeal elevation and carotid pulse. Thedetected signals are transmitted to the Health Management application(on the companion device, such as a smartphone) for acoustic processingand analysis. The analysis, for example, differentiates between a dry(not associated with eating) and a wet (associated with eating) swallowby considering at least the repetitiveness of a plurality of swallowevents, time elapsed between the plurality of swallow events and theoverall duration encompassing the plurality of swallow events. Thus, insome embodiments prolonged occurrence of a plurality of swallow eventsmay be considered as consumption of a meal. In various embodiments, theswallow detection sensor 4005 is configured to be worn or adhered to theuser's skin so as to cover an optimal site for swallow detection. Inembodiments, the optimal site comprises any one of: a) a lateral borderof the trachea immediately inferior to the cricoid cartilage, b) acenter of the cricoid cartilage and the midpoint between the site overthe center of the cricoid cartilage and c) a site immediately superiorto the jugular notch.

In various alternate embodiments, impedance and/or acoustic detection ofgastric sounds, at the level of the user's stomach, are utilized todetermine an eating event.

In accordance with another embodiment of the present specification, aneating activity or eating moment of the user is determined automaticallyusing an inertial sensor, such as an accelerometer or inclinometer, forautomated dietary monitoring. In various embodiments, the accelerometeror inclinometer is included in a wrist-band or wristwatch, such as theband 2105 of FIG. 21A or the wristwatch 2106 of FIG. 21B, to detect,capture and acquire a plurality of dietary data related to physical bodymovements, such as (for example) haptic motions of the wrist or hand, ofthe user involved in food intake gestures (also referred to as thehand-to-mouth gestures). The plurality of dietary data is communicatedto the Health Management application that implements an eating momentrecognition method to process and analyze the plurality of dietary dataand identify when the user is eating. In accordance with an embodiment,the eating moment recognition method a) performs eating gesturedetection on the plurality of dietary data captured by the accelerometerincorporated within the wristband or wristwatch/smartwatch of the user,and b) clusters these eating gestures across a time dimension toidentify eating moments or activities.

In embodiments where the Health Management application is incommunication with an Intelligent Personal Assistant (IPA), as discussedlater in this specification, identification or determination of aneating moment or activity (by the eating moment recognition method) bythe HMA is communicated to the IPA that may deliver auditory prompts touser enquiring if the user is indeed eating and if yes, then cautioningthe user if the eating event is unscheduled or not in line with a mealregimen being followed by the user. In some embodiments, the eatingmoment recognition method is implemented directly by the IPA device suchthat dietary data from the wristwatch or band is communicated directlyto the IPA device (in communication with the wristwatch or band) fordetecting eating events or activities.

FIG. 58 is a flow chart of a plurality of exemplary steps of the eatingmoment recognition method, implemented by the HMA, in accordance withsome embodiments. At step 5805, a user wears a wrist-worn device, suchas a wristband or wristwatch/smartwatch, comprising at least anaccelerometer that continuously captures, and communicates to the HMA, aplurality of dietary data representative of the user's food intakegestures. The HMA receives and stores the plurality of dietary data fromthe accelerometer. At step 5810, the plurality of dietary data isfiltered using a filter such as, but not limited to, anexponentially-weighted moving average and thereafter scaling theresulting filtered data to unit norm (such as, for example, 12normalization). At step 5815, data frames are extracted, from theresulting filtered and normalized data of step 5810, using a slidingwindow approach with a predefined overlap, such as, say, 50% overlap. Itshould be appreciated that a frame size is chosen so that the extractedframes contain an entire food intake gesture. The gesture duration isbased on factors, such as the user's eating styles and whether he ismultitasking (e.g., reading a book, socializing with friends) whileeating or drinking. In various embodiments, the frame size ranges from aduration of 2 to 10 seconds. In an embodiment, the frame size is chosento be of 6 seconds duration.

At step 5820, a plurality of statistical functions are computed for eachextracted frame. In one embodiment five statistical functions arecomputed comprising the frame's mean, variance, skewness, kurtosis androot mean square. These frame-level features result in 5-dimensionalfeature vectors for each axis of the accelerometer, in accordance withan embodiment.

At step 5825, the user's food intake gestures (defined as the arm andhand gestures involved in bringing food to the mouth from a restingposition on a table, for instance, and then lowering the arm and handback to the original resting position) are identified using a classifiersuch as, but not limited to, the Random Forest learning algorithm or theScikit-learn Python package.

Thereafter, at step 5830, the user's eating moments or activities areestimated based on temporal density of the identified food intakegestures. When a predefined minimum number of identified food intakegestures are within a predefined temporal distance of each other, thensuch an event is construed as an eating moment or activity. Inembodiments, a density-based clustering algorithm, such as DBSCAN(Density-based spatial clustering of applications with noise), is usedto identify high food intake gesture densities as clusters in the timedomain. In an embodiment, the centroids of these clusters are identifiedas eating moment occurrences.

In accordance with another aspect of the present specification, theaccelerometer or inclinometer included in the wrist-band or wristwatch,such as the band 2105 of FIG. 21A or the wristwatch 2106 of FIG. 21B, isused to detect, capture and acquire a plurality of gesture datacorresponding to a plurality of pre-defined haptic motions of the wristof the user. In embodiments, the plurality of pre-defined haptic motionsof the wrist are indicative of a plurality of user-initiated commandsand/or inputs to the HMA.

Accordingly, the eating moment recognition method of FIG. 58 isconfigured to detect and interpret the plurality of pre-defined hapticmotions of the wrist of the user. For example, a number (say three ormore) of repetitive circular motions of the hand—using wrist as apivot—may be detected and interpreted by the eating moment recognitionmethod to be indicative of the user wanting to trigger a standard orpre-programmed stimulation session (pre or post prandial) or to triggera hunger or appetite scale to record an unscheduled hunger event andconsequently trigger a rescue stimulation session. In some embodiments,the direction of such repetitive circular motions of the hand may befurther differentiated to indicate differing commands and/or inputs bythe user. For example, in one embodiment, a clockwise rotatory motion ofthe hand—using the wrist as the pivot—may be detected and interpreted tobe indicative of the user wanting to trigger a standard orpre-programmed stimulation session (pre or post prandial) while ananti-clockwise rotatory motion may be indicative of the user wanting totrigger a hunger or appetite scale to record an unscheduled hunger eventand consequently trigger a rescue stimulation session.

Let us say that the user rotates his hand anti-clockwise, with wrist aspivot, causing the hunger VAS bar scale to be triggered on hiswrist-band or wristwatch. Next, in some embodiments, the user may movehis hand up-and-down in a vertical plane, with the wrist as a pivot, toinput and record the intensity of hunger he is experiencing. Forexample, the number of times the user moves his hand up-and-down may beindicative of a level of hunger the user wants to input. Thus, on ahunger scale of 1 to 5, one up-and-down movement of the hand mayindicate a level 1 hunger intensity while 5 successive up-and-downmovements of the hand may correspondingly indicate a level 5 hungerintensity. In alternate embodiments, the user may move his handside-to-side in a horizontal plane, with the wrist as a pivot, to inputand record the intensity of hunger he is experiencing. Thus, the numberof times the user moves his hand side-to-side may be indicative of thelevel of hunger the user wants to input.

In accordance with still another aspect of the present specification,the wrist-band or wristwatch includes a touch-sensitive display screenconfigured to accept and subsequently interpret the user's taps and/orswipes. In a non-limiting example, the user may trigger the hunger VASbar scale by rotating his hand anti-clockwise, with wrist as pivot.Next, the user may use a specific number of taps or swipes on thedisplay screen of his wrist-band or wristwatch to input and record theintensity of hunger he is experiencing. Thus, on a hunger scale of 1 to5, a single tap or swipe would indicate a level 1 of hunger intensitywhile a series of 5 taps or swipes would indicate a level 5 of hungerintensity. It should be appreciated that in embodiments, any one or acombination of the plurality of haptic motions of the hand (using wristas a pivot) and taps or swipes on the display screen (of the wrist-bandor wristwatch) may be used to enable the user to issue commands and/orinputs to the HMA.

In yet further embodiments, the Health Management application is capableof also detecting and communicating with a plurality of wirelessproximity sensor tags. The plurality of proximity tags are located atpotential areas of meal sourcing and/or consumption such as, but notlimited to, refrigerator, pantry, kitchen, and dining room to detect theuser's proximity at these areas. If the user's presence, at these areas,is detected the HMA may prompt and caution the user with reference toout-of-plan meal consumption, for example.

In accordance with aspects of the present specification, multipleelectro-dermal patch (EDP) devices along with a plurality of additionaldevices when paired or synced with at least one companion device of auser—constitute a health or therapeutic network or eco-system for theuser. Similarly, health or therapeutic networks or eco-systems of aplurality of users are networked together to form a large or wide-areahealth or therapeutic eco-system (stylized as an Internet of Things). Inembodiments, additional devices comprise devices such as, but notlimited to, third party devices (with physiological sensors) configuredto be worn on the human body such as around the wrist, a glucose sensor,an IPA (Intelligent Personal Assistant) system (as described in detaillater in the specification), proximity sensor tags, a swallow detectiondevice (such as device 5605 of FIG. 56), Bluetooth activated locks, andkitchen appliances (such as a refrigerator). In embodiments, the healthor therapeutic network or eco-system allows connecting any wire orwirelessly sync-able additional devices. In some embodiments, the healthor therapeutic network or eco-system allows a subset of the additionaldevices to be preferentially synced such as, for example, the thirdparty devices (with physiological sensors).

In some embodiments, multiple electro-dermal patch (EDP) devices 110 arenetworked together with a single companion device 105 to aggregate datafeedback from the EDP devices 110. The aggregated data is then used tomodify stimulation parameters and develop more precise stimulationalgorithms. In various embodiments, the companion device 105 enablessocial networking with friends and family, provides voice recognitionand voice feedback, and includes anti-hacking data protection for HIPAAcompliance. In some embodiments, the wireless connection (for pairing orsyncing) is optionally compliant with HIPAA and other regulatory bodyrequirements and laws relating to OUS (Outside United States) countriesfor patient data privacy. In various embodiments, the wirelessconnection is encrypted to prevent hacking of the device to retrievepatient data and/or inappropriately stimulate the patient and/or destroythe device.

In various embodiments, as shown in FIG. 6B, using a companion device625, 635, 645, 655, 665 multiple EDP users 620, 630, 640, 650, 660 cannetwork with one another and communicate regarding their therapy over ashared network connection 621, such as a cloud based connection, whichcan lead to improved patient compliance to stimulation protocols, withresultant increased dietary compliance. For example, networked EDP userscould share and exchange experiences, progress, dietary ideas, andsuccess stories. In some embodiments, networked exchanges areautomatically input into companion devices, resulting in changes totherapy provided by the EDP devices. For example, in one embodiment,aggregated dosing data is used to reset baseline default dosing settingsto provide different dietary recommendations. Traditionally, small groupclinical studies are performed to obtain data used for creating dosingstrategies. By networking EDP users through companion devices, largeramounts of aggregated user settings can be obtained automatically, forexample, via a cloud based connection, and used to automatically finetune dosing settings. In some embodiments, EDP users have the ability,over a network connection, to share data among friends and family whoare also users. In some embodiments, EDP users can be segmented intodiet clubs based on their connected friends and/or based on the type ofdiet they have chosen. Therefore, in various embodiments, users canconnect with friends and also connect into “groups” defined around thetype of diet plan, i.e. Atkins, Mediterranean, and intermittent fasting,they are following. Further, in some embodiments, users connected to agroup, for example, Weight Watchers, can receive “group therapy” supportin the form of input, as needed or at periodic intervals, from amoderator or therapist. In embodiments, the “groups” also enablecommunication between EDP devices, between users, and between users anda moderator or therapist. Such interconnectivity among friends, groups,and moderators/therapists provides a larger support network for EDPusers and promotes user compliance.

In some embodiments, an EDP user network functions as a dosing settingsand dietary information exchange. For example, in an aggregate patientdata network, multiple different patients have an EDP communicating witha personal companion device. FIG. 6C is a flow chart listing the stepsin one embodiment of a method of aggregating, organizing, and analyzingstimulation parameters and patient hunger, appetite, and well-beingscores for a plurality of patients, each having an EDP device withlinked companion device connected to an aggregate patient network. Atstep 672, each patient connects to the aggregate patient network usingtheir companion device. At step 674, periodically, e.g. several times aday, once a day, 2-6 times a week, or any such increment, anonymizeddata regarding the patient's stimulation parameters including, but notlimited to, stimulation pulse width, pulse amplitude, pulse frequency,pulse shape, duty cycle, session duration, and session frequency,together with the patient's corresponding hunger, appetite, andwell-being scores (the hunger, appetite, and well-being scores beingcollectively referred to as patient status data), are transmitted to acentral server, or set of servers.

At the central server, at step 676, the anonymized data from multipleusers are organized into a collective database and analyzed todetermine 1) the stimulation parameters including, but not limited to,stimulation pulse width, pulse amplitude, pulse frequency, pulse shape,duty cycle, session duration, and session frequency, which typicallylead to sufficient appetite suppression without an unacceptabledecrement in well-being and 2) the stimulation parameters including, butnot limited to, stimulation pulse width, pulse amplitude, pulsefrequency, pulse shape, duty cycle, session duration, and sessionfrequency, which typically lead to sufficient appetite suppressionwithout an unacceptable decrement in well-being for specific demographicsectors. In some embodiments, patient status data such as the hunger andappetite scores are aggregated into a composite score, also referred toas a satiety score. In some embodiments, exercise scores reflective ofcalories expended are also factored into the composite or satiety score.The user can share her composite score (along with treatment orstimulation settings that led to the composite score) with friends andfamily via social networking (and/or with an online coaching orconcierge service), to illicit advice, encouragement and compareprogress with fellow dieters.

It should be appreciated that while in some embodiments data regardingthe patients' stimulation parameters is anonymized, in some embodimentsthe data may not be anonymized if the patients sign away theirrespective privacy rights.

In various embodiments, hunger and appetite scores across demographicprofiles are analyzed to determine what stimulation settings achieveoptimum appetite and hunger levels or scores for a given age, gender,race, body fat, BMI, ethnicity, weight loss goal, or bacterialmicrobiome profile. Thus, for a given user, once the optimum stimulationsettings are identified, it is then determined how stimulation settingsfor the given user must be modified, titrated or personalized in orderto match those optimum stimulation settings, and a modulation signal istransmitted in order to establish those new (optimum) stimulationsettings. In various embodiments, the electrical stimulation dosingsettings are titrated and personalized from one user and/or user groupto another user and/or user group based on optimum stimulation settingstracked, analyzed and determined across various group demographicprofiles.

In various embodiments, the EDP device, and the electrical stimulationit delivers, is configurable and re-configurable for different therapiesand for different aspects within a specific therapy. For example,regarding weight loss and management, the patient and/or companiondevice can configure the EDP to deliver electrical stimulation in aneffort to promote active weight loss in the patient and then, once atarget weight is achieved, reconfigure the EDP to deliver electricalstimulation to maintain the patient at the target weight. This can beaccomplished via one or more applications downloaded to the companiondevice. FIG. 6D is a flow chart illustrating the steps involved in usingone or more downloadable applications to configure and reconfigurestimulation provided by an electro-dermal patch (EDP) device, inaccordance with one embodiment of the present specification. At step680, a patient obtains an EDP from a medical professional. At step 681,the patient pairs a companion device with the EDP and with a separatephysiological monitoring device with physiological sensors, configuredto be worn on the human body, such as around the wrist, in order tomonitor, acquire, record, and/or transmit physiological data to thecompanion device, wherein the companion device is adapted to create andmodify stimulation parameters based on the monitored physiological data.At step 682, the patient then downloads, from an online marketplace, afirst application designed to configure the EDP to achieve a firstobjective associated with a specific therapy, for example, weight lossfor weight management. The patient positions the EDP on his body at step683. The first application, at step 684, configures the EDP for thefirst objective by establishing certain baseline stimulation parametersdesigned to achieve said first objective and by titrating or fine-tuningsaid stimulation parameters based on patient diary input into thecompanion device and/or physiological data transmitted to the companiondevice by the separate monitoring device. After the first objective hasbeen achieved, at step 685, the patient then downloads a secondapplication, from an online marketplace, designed to reconfigure the EDPto achieve a second objective associated with the specific therapy, forexample, maintaining weight for weight management.

In various embodiments, one or both of the first and second applicationsis available from the online marketplace for a fee. Additionally, boththe first and second applications may be separate and distinctapplications which reside on the companion device, are separatelyobtained by accessing the on-line application marketplace associatedwith the companion device, and are activated, and executed, by clickingon separate and distinct icons from the companion device's home screen.In another embodiment, the first application may be downloaded from theon-line application marketplace associated with the companion device andmay be activated, and executed, by clicking on separate and distincticons from the companion device's home screen while the secondapplication, and all subsequent applications responsible for modulatingthe EDP's stimulation parameters, are downloaded by accessing amarketplace of such applications through the first application.Specifically, the first application provides a gateway to a database, orlibrary, of additional applications which may provide for differentstimulation parameters based on inputs, weights, and other criteria thatdiffer from the first application, or each other.

The second application, at step 686, then configures the EDP for thesecond objective by establishing certain baseline stimulation parametersdesigned to achieve said second objective and by titrating orfine-tuning said stimulation parameters based on patient diary inputinto the companion device and/or physiological data transmitted to thecompanion device by the separate monitoring device. In one embodiment,for weight management, the stimulation parameters for the firstobjective (weight loss) are more focused on patient diary record ofwell-being and hunger as inputs to titrate therapy while the stimulationparameters for the second objective (weight maintenance) are morefocused on daily body weight as an input to titrate therapy. Whileweight management has been used to describe the method above formodifying therapy provided by the EDP, in various embodiments, themethod of using one or more online applications to configure andreconfigure the stimulation parameters of the EDP can be used on anycondition receptive to electrical stimulation therapy.

In various embodiments, the EDP and companion device are open source toallow for the creation of applications for the devices designed to enacttherapy methods similar to the one described above. In anotherembodiment, a single master application downloadable to a companiondevice is responsible for controlling the EDP and setting initialstimulation parameters. This master application may come with the EDPupon initial purchase or may be separately purchasable or downloadablefor free from an online marketplace. In various embodiments, furthersoftware upgrades, such as in-application or “in-app” purchases, can beobtained, for a fee, within the master application and used to fine-tunetherapy. In various embodiments, such software upgrades include, forexample, new diet plans, new exercise plans, and improved fitnesstracking, among others. In various embodiments, these software upgradesare created by third parties or by the creator of the masterapplication. In some embodiments, new applications or software upgradesto a master application reconfigure the EDP to provide electricalstimulation targeting different conditions. For example, in variousembodiments, applications or upgrades reconfigure baseline EDPstimulation parameters to treat other conditions including, but notlimited to, dysmenorrhea, back pain, urinary incontinence, andperipheral neuropathy, including diabetic peripheral neuropathy. In someembodiments, the electrical components of the device are the same andthe patient uses a different, disposable electrode patch portion andrepositions the device on his or her body. These applications andupgrades modify the algorithms used by the companion device to changethe stimulation parameters for the EDP to treat the differentconditions. For example, in one embodiment, a patient initially uses theEDP for weight management in a method similar to that described above.She then downloads a fee based online application to the companiondevice which then reconfigures the EDP stimulation to treat herdysmenorrhea. She can then use her initial application to return the EDPback to weight management settings. She could continually download newapplications and upgrades and reconfigure the EDP to treat a pluralityof different conditions and go back and forth between differentconditions. It would be preferred that, for the non-weight lossapplications, such as urinary incontinence, back pain, dysmenorrhea andperipheral neuropathy, including diabetic peripheral neuropathy, acompletely different application be downloaded while for new ordifferent weight loss plans, it would be preferred to downloadadditional applications through the first downloaded weight lossapplication itself, thereby avoiding having multiple different anddistinct weight loss applications on the companion device's home screen.

Because the presently disclosed embodiments are directed to medicaltreatments, it is imperative that patient specific data, such as datarepresenting specific stimulation settings and patient status data, arestored, transmitted, and verified in a manner that is secure and subjectto authentication. In one embodiment, data transmissions between theEDP, the companion device, and any remote server(s) are subject toverification and authentication, such as by using checksums, private andpublic keys, and other forms of verification known in the art. If, atany time, one or more of the data transmissions fail to be properlyverified or authenticated, any new or modulated stimulation settingsassociated with such data transmissions are discarded or otherwise setaside and only a previous stimulation setting associated with a fullyverified and/or authenticated complete set of data transmissions isused. Alternatively, the system may lock the use of any stimulationsetting until such data transmissions can be fully verified, along withany new or modulated stimulation settings associated therewith.

FIG. 6E is a flow chart illustrating the steps involved in a method of acompanion device verifying and/or authenticating data transmissionreceived from a remote server, in accordance with some embodiments ofthe present specification. At step 690, a patient obtains anelectro-dermal patch (EDP) device from a medical professional. Thepatient pairs a companion device with the EDP and with a remote server,in a secure manner subject to verification and authentication, at step691. At step 692, the companion device receives a data transmissioncomprising new or modulated stimulation settings from the remote server.The companion device then checks if the data transmission is properlyverified and/or authenticated at step 693. In one embodiment, if thedata transmission is properly verified and/or authenticated, thecompanion device controls the EDP to deliver electrical stimulationbased on the new or modulated stimulation settings at step 694. In oneembodiment, if the data transmission is not properly verified and/orauthenticated, the new or modulated stimulation settings are discardedor otherwise set aside and a previous stimulation setting associatedwith a fully verified and/or authenticated complete set of datatransmissions is used at step 695. In another embodiment, if the datatransmission is not properly verified and/or authenticated, thecompanion device locks the use of any stimulation setting until the datatransmission can be fully verified, along with any new or modulatedstimulation settings associated therewith at step 696.

In another embodiment, communications between an EDP, companion deviceand any remote server(s) may comprise an indication, such as a packetheader, identifier, tag, or other representation, of whether thespecific EDP involved in the data transmissions is a device that hasbeen sold subject to FDA regulatory approval or whether it is a devicethat has not been sold subject to FDA regulatory approval. Depending onsuch an identifier (indicative of government regulatory governance, orsome extent thereof), different data processing may occur. For example,if the companion device or remote server(s) determine the EDP inquestion is subject to FDA approval (based on an identifier being storedin a memory within the EDP), it may cause a different or higher level ofencryption, authentication, and/or verification to be applied to thestored data or to data transmissions. In one case, all datatransmissions to and from the EDP, between the EDP and companion device,and/or between the companion device and remote server(s) are encrypted,authenticated, and anonymized subject to verification. In another case,only data transmissions containing patient-specific stimulation settingsor patient status data are encrypted, authenticated, and/or subject toverification while all other data transmissions are not encrypted.

If, on the other hand, the companion device or remote server(s)determines the EDP in question is not subject to FDA approval (based onan identifier being stored in a memory within the EDP), it may cause alower level of encryption, authentication, and/or verification to beapplied to the stored data or to data transmissions relative to the FDAcase. In one embodiment, no data transmissions to and from the EDP,between the EDP and companion device, and/or between the companiondevice and remote server(s) are encrypted, authenticated, and subject toverification. In another case, only data transmissions containingpatient-specific stimulation settings or patient status data areauthenticated and/or subject to verification and no data transmissionsare encrypted.

FIG. 6F is a flow chart illustrating the steps involved in a method ofencrypting, authenticating, and/or verifying data transmissions betweenan EDP, companion device, and remote server based on FDA approval statusof the EDP, in accordance with some embodiments of the presentspecification. At step 661, a patient obtains an electro-dermal patch(EDP) device from a medical professional. The patient pairs a companiondevice with the EDP and with a remote server, in a secure manner subjectto verification and authentication, at step 662. At step 663, thecompanion device and/or remote server determine if the EDP is subject toFDA approval based on an indication (packet header, identifier, tag) onthe EDP. In one embodiment, if it is determined that the EDP is subjectto FDA approval, then all data transmissions to and from the EDP,between the EDP and companion device, and/or between the companiondevice and remote server are encrypted, authenticated, and subject toverification at step 664. In another embodiment, at step 666, if it isdetermined that the EDP is subject to FDA approval, only datatransmissions containing patient-specific stimulation settings orpatient status to and from the EDP, between the EDP and companiondevice, and/or between the companion device and remote server areencrypted, authenticated, and/or subject to verification and all otherdata transmissions are not encrypted. In another embodiment, if it isdetermined that the EDP is not subject to FDA approval, then no datatransmissions to and from the EDP, between the EDP and companion device,and/or between the companion device and remote server are encrypted,authenticated, and subject to verification at step 667. In anotherembodiment, at step 669, if it is determined that the EDP is not subjectto FDA approval, only data transmissions containing patient-specificstimulation settings or patient status to and from the EDP, between theEDP and companion device, and/or between the companion device and remoteserver are authenticated and/or subject to verification and no datatransmissions are encrypted.

In accordance with an aspect of the present specification, patientstatus data and, if needed, stimulation setting, parameters andprotocols are transmitted to insurance companies to support medicaltreatments, such as bariatric surgeries, or other insurance claims, orfor other general insurance data needs. In some embodiments, such datatransmission may be subjected to encryption, authentication andverification as described at step 666.

The Health Management Application (hereinafter also referred to as‘HMA’) of the present specification comprises a plurality ofprogrammatic instructions and algorithms and implements a plurality ofGUIs (Graphical User Interface) to enable a plurality of functions,non-limiting examples of which are described henceforth.

Referring back to FIG. 1A, in various embodiments, the HMA enablesconfirming linkup to the electro-dermal patch device 110 and displayingbattery life of the electro-dermal patch device 110. In embodiments, theEDP device 110 goes into a sleep mode or state periodically, when notstimulating for example, to conserve power. In the sleep mode or ‘off’state the EDP device 110 uses a minimum amount of power. As a result ofbeing in the low power state, a Bluetooth connection between the EDPdevice and the associated companion device (the hand-held computingdevice 105) may be lost or the pairing or synchronization between theEDP device and the companion device may be lost. Also, the Bluetoothconnection may be lost if a distance between the EDP device and thecompanion device increases beyond a certain limit. To ensure appropriateconnection between the EDP device and the companion device, the HMAenables generating an audio, visual and/or tactile (such as, vibratory)alarm if the Bluetooth connection between the EDP device and thecompanion device deteriorates and the EDP device is not detectable.

The HMA enables generating an audio and/or visual indicator on thehand-held computing device 105 indicating that a) the electro-dermalpatch device 110 has been properly placed on the user's body by, forexample, confirming sufficient electrode and tissue contact orintegrity, b) the one or more electrodes 118 is aged or compromised(ascertained by, for example, impedance measurements) and needs to bereplaced. In some embodiments, electrode and tissue contact integrityand electrode integrity, i.e. whether the electrode is functioningproperly or damaged, are checked through at least one sensor, such as animpedance or bio-impedance sensor of the electro-dermal patch device110. In other embodiments, an acoustic sensor, capable of sensingspecific acoustic signals unique to an area of the human body, is usedto determine if the electro-dermal patch device 110 has been properlypositioned on the user's body. In various embodiments, sufficientelectrode and tissue contact or integrity is defined as achievingelectrode impedance in a range of 200 ohms to 1000 ohms. In oneembodiment, pulse amplitude is automatically adjusted by virtue of therebeing a constant current source (from one or more batteries). A constantcurrent source circuit automatically adjusts the pulse to maintain aprogrammed amplitude in the event of electrode-tissue interfaceimpedance changes. This automatic adjustment may be programmed to occurfor voltages ranging from 0.1V to 500V. Accordingly, the pulse amplitudeis automatically modulated in order to maintain a constant currentsource. In other words, the stimulation pulse amplitude or intensity isadapted automatically as a function of electrode-tissue interfaceimpedance changes. In some embodiments, the pulse intensity varies as adirectly proportional function of the electrode-tissue interfaceimpedance changes. In some embodiments, the pulse intensity varies as adirectly inverse proportional function of the electrode-tissue interfaceimpedance changes.

The HMA also enables analyzing sensed neural activity prior to thecommencement of a stimulation therapy to assess and indicate to the userthat the electro-dermal patch device 110 has been placed at anappropriate location, such as the T2-T12 and/or C5-T1 dermatomes foreating disorders. In various embodiments, the accuracy orappropriateness of the electro-dermal patch device location is assessedthrough the neural activity monitor of the electro-dermal patch device110. In various embodiments, neural activity sensing or monitoring isaccomplished by using a sense amplifier circuit to measure neuralactivity and output a representative signal to the microcontroller ormicroprocessor of the electro-dermal patch device 110. Themicrocontroller algorithmically processes the data to determine if thereis neural activity. In some embodiments, the sense amplifier circuitmeasures neural activity signals directly using the same electrodes usedfor stimulation. In other embodiments, the sense amplifier circuitmeasures neural activity signals separately using different electrodesthan those used for stimulation. In still other embodiments, the senseamplifier circuit measures neural activity signals using both the sameelectrodes used for stimulation and different electrodes than those usedfor stimulation. In various embodiments, the sense amplifier circuitincorporates a gain in a range of 1 to 100,000,000 and all values inbetween, and incorporates a bandpass filter of 0.1 Hz to 10,000 Hz andall combinations in between. These functions are accomplished usingconventional analog circuity known in the art, such as operationalamplifier circuits and transistor circuits. In one embodiment, a processused by the microprocessor to process the sensed neural activitycomprises counting the number of events within a predetermined timeperiod. In other embodiments, the process is modified to add movingaverages in the form of finite impulse response (FIR) or infiniteimpulse response (IIR) digital filters.

The HMA enables the user to self-administer therapy, including theability to stimulate multiple times per day or per week, therebyaccelerating treatment effect and efficacy. In various embodiments, theself-administration is on-demand and is actuated via a button on thecompanion device 105 used to trigger the electro-dermal patch device110. Triggering the electro-dermal patch device 110 is defined astriggering a protocol that may result in stimulation over a predefinedperiod and does not necessarily indicate electrical stimulation beginsimmediately. The companion device 105 and/or electro-dermal patch device110 include pre-programmed restrictions which prevent the patient fromover-stimulating. In addition, the companion device 105 and/orelectro-dermal patch device 110 include triggers which prompt thepatient to stimulate based upon time of day, historical trends inappetite, caloric intake, and exercise data.

The HMA also enables analyzing sensed neural activity during astimulation therapy to assess effectiveness of the stimulation.Depending upon the effectiveness, the Health Management application mayautomatically recommend and/or implement adjustments or modifications toa plurality of stimulation parameters. In some embodiments, therecommended adjustments to the plurality of stimulation parameters mustbe accepted or authorized for implementation by at least one of the user(that is, the patient) and/or the remote patient care facility orpersonnel. In various embodiments, neural activity is sensed using asense amplifier circuit as described above.

The HMA enables the user to input his current weight per day through aGUI screen and provides real-time or near real-time integration offeedback from patient parameters such as, but not limited to, exerciseand fitness, diet, hunger, appetite, and well-being, recorded in apatient daily diary, from the patient and obtaining real-time or nearreal-time integration of feedback, such as steps taken as an indicatorof calories burned, from other wearable devices, for example, a device,with physiological sensors, configured to be worn on the human body,such as around the wrist, in order to monitor, acquire, record, and/ortransmit the physiological data, allowing for frequent adjustability andcustomization of therapy as needed. The integration of feedback from thepatient and from other devices allows for modification of therapy, asneeded, to suppress appetite and treat conditions such as obesity,over-weight, and/or metabolic syndrome. In accordance with variousaspects of the present specification, the electro-dermal patch deviceenables treating people with BMI (Body Mass Index) of 25 or greater(overweight being 25-30, obese being 30 and above, with morbid obesitybeing above 35).

The HMA enables providing recording, storage and display of allstimulation parameters and other real-time inputs, such as diary andexercise monitoring, to provide the physician and patient real-timerecords and treatment profiles. The information stored includes acombination of inputs from the stimulation device and from other sourcesof information, for example, from a device, with physiological sensors,configured to be worn on the human body, such as around the wrist, inorder to monitor, acquire, record, and/or transmit the physiologicaldata. In accordance with an aspect, the HMA enables the patient torecord her daily diary parameters (such as, hunger, appetite,well-being, exercise) using emoticons displayed to the patient on atouch-screen display, for example, of the companion device. In anexample, to record an intensity of hunger the patient may be visuallypresented or prompted with a plurality of bear emoticons showing varyinglevels of empty stomach. In other words, a bear emoticon with an emptystomach may be indicative of a high level of hunger or appetite whereasa bear emoticon with a more full stomach may be indicative of a lowlevel of hunger or appetite. On a scale of 0 to 5 or 0 to 10, the lowestlevel of hunger or appetite (corresponding to 0) may be indicated with abear emoticon with a completely full stomach, the highest level ofhunger or appetite (corresponding to 5 or 10) may be indicated with abear emoticon with a completely empty stomach whereas the intermediatelevels of hunger or appetite may be indicated with bear emoticons havingcorrespondingly varying degrees of full or empty stomach. Thus, thepatient is visually presented or prompted with a plurality of icons oremoticons wherein each of the plurality of icons is representative of adifferent degree of hunger or appetite.

The HMA enables communication with one or more third party serviceproviders for user activated or automated ordering of accessories, suchas electrode patches for example, standard meals, such as Jenny Craig,or fitness coaching services. HMA's enablement of communication with oneor more third party service providers also allows for sourcing andpaying for online services and/or for advertising.

The HMA enables presenting GUI screens to enable the user to provideinputs such as, but not limited to, eating information and activitiesinformation. In various embodiments, eating information comprisesstandard regular eating and meals profile or routine of the user such asthe number of meals per day typically consumed and the types and amountsof food eaten at each of the meals per day. For example, in someembodiments, the standard regular eating and meals profile of the usercomprises at least the number and timing of meals per day (such as threedaily meals; breakfast at 8:00 am, lunch at noon and dinner at 6:00 pm).The user is enabled to manually adjust the timings of the meals. Thestandard regular eating and meals profile is typically input only onceby the user as it represents the general eating habit of the user and islikely to be modified by the user over long periods of time. In someembodiments, the standard regular eating and meals profile isrepresentative of a standard diet plan such as, but not limited to,Mediterranean, Intermittent Fasting, Jenny Craig, Weight Watchers,SlimFast and Custom Plan.

In various embodiments, eating information additionally or alternativelycomprises real time actual eating and meals profile of the user such asthe time of consumption of a meal in a day and the type and amount offood eaten at the meal. In other words, each time the user consumes ameal he (in real time) records the occurrence of the meal event, whichis automatically time stamped by the application, as well as the typeand amount of food eaten. If the meal being consumed and the type andamount of food are in line with the user's standard regular eatingprofile, he may simply select the meal and types and amounts of foodfrom the pre-stored eating profile of the user.

In various embodiments, the HMA in communication with a swallowdetection device, such as the device 5605 of FIG. 56, detects if theuser is engaged in an eating event. In alternate embodiments, the user'seating event, activity or moment is determined automatically using aninertial sensor, such as an accelerometer, for automated dietarymonitoring. In embodiments, the accelerometer is included in awrist-band or wristwatch, such as the band 2105 of FIG. 21A or thewristwatch 2106 of FIG. 21B, to detect, capture and acquire a pluralityof dietary data related to physical body movements of the user involvedin food intake gestures. The plurality of dietary data is communicatedto the Health Management application that implements an eating momentrecognition method (FIG. 58) to process and analyze the plurality ofdietary data and automatically identify when the user is eating.

Detection of the eating event causes the HMA to perform any one or acombination of the following actions: prompt the user to input the typeand amount of meal being consumed, provide the user with healthier foodoptions (such as via an Intelligent Personal Assistant system describedlater with reference to FIGS. 48A through 48C), automatically time stampthe meal consumption event, automatically determine if the mealconsumption is or is not in line with the user's standard regular eatingprofile, advise the user to avoid having the meal if the mealconsumption is not in line with the user's standard regular eatingprofile (that is, is an out of schedule or plan eating event),automatically trigger a stimulation session during meal consumptionand/or post-prandial, that is after the user has finished consuming themeal.

In accordance with an aspect of the present specification, the real timeeating and meals profile is utilized to calculate the actual amount ofcalories consumed by the user in a day. On the other hand, the standardregular eating and meals routine of the user is utilized to calculate aforecasted or expected amount of calories likely to be consumed by theuser in a day. A difference between the daily, weekly or monthlyexpected and actual calories consumption value may prompt a plurality ofrecommendations from the Health Management application to the user.

In accordance with some aspects of the present specification, it isadvantageous to also assess the quality of meal or diet consumed alongwith the amount of calories consumed as a result of the meal or diet ina day. In some embodiments, the quality of a meal or diet is determinedbased on a mix of macronutrients such as carbohydrates (also referred toas “carbs”), proteins and fats present in the meal or diet. Thus, theuser's standard diet plan may propose an acceptable ratio for eachmacronutrient. For example, the Zone Diet (by Barry Sears, PhD) proposesa meal of 40% carbs, 30% protein and 30% fats, the Atkins Diet proposesa meal of 5% carbs, 25% protein and 75% fats, while the Ketogenic Dietproposes a meal of 10% carbs, 45% protein and 45% fats. Thus, for a userwho is endeavoring to follow a standard diet plan or a custom diet plandesigned around a specific ratio of macronutrients, the expected ratioof macronutrients and the expected calories likely to be consumed in aday are known and pre-stored by the Health Management application.

In various embodiments, the actual or real time eating and meals profileof the user is indicative of the time of consumption of a meal in a dayas well as the type and amount of food eaten at the meal. The type andamount of food eaten enables calculating the calories consumed as wellas a ratio of macronutrients, that is, carbs, protein and fats consumed.It should be appreciated that while in some embodiments, the HealthManagement application calculates the ratio of all three macronutrients,(carbs, proteins and fats) consumed in a meal, in various alternateembodiments, an amount and effect of any one or two macronutrients maybe monitored and calculated. For example, in some embodiments, theHealth Management application is focused on monitoring and determiningthe effect of carbohydrates consumed compared to an acceptable amount ofcarbohydrates allowed based on the standard diet plan being followed bythe user.

Thus, in accordance with an aspect, carbohydrate containing foods arerated on a scale called the glycemic index (GI) and the glycemic indexis used to calculate a glycemic load (GL) associated with the foodconsumed. The GI ranks carbohydrate containing foods based on theireffect on blood sugar levels over a period of time. Carbohydratecontaining foods are compared with glucose or white bread as a referencefood, which is given a GI score of 100. The GI compares foods that havethe same amount of carbohydrate, gram for gram. Carbohydrates that breakdown quickly during digestion have a higher glycemic index (say, GI morethan 70). These high GI carbohydrates, such as a baked potato, releasetheir glucose into the blood quickly. Carbohydrates that break downslowly, such as oats, release glucose gradually into the bloodstream.They have low glycemic indexes (say, GI of approximately less than 55).The blood glucose response is slower and flatter. Low GI foods prolongdigestion due to their slow break down and may help with satiety.

The glycemic index compares the potential of foods containing the sameamount of carbohydrate to raise blood glucose. However, the amount ofcarbohydrate consumed also affects blood glucose levels and insulinresponses. The glycemic load (GL) takes into account both the GI of thefood and the amount of carbohydrate in a portion or serving consumed. GLis based on the idea that a high GI food consumed in small quantitieswould give the same effect on blood glucose levels as larger quantitiesof a low GI food. GL is calculated by multiplying the GI by the amountof carbohydrates (in grams) in a serving of food.

Thus, in accordance with another aspect of the present specification,the real time eating and meals profile is utilized to calculate theratio of macronutrients, that is, carbs, proteins and fats, consumed ina day or at least the glycemic load (GL) associated with the mealsprofile. On the other hand, the standard regular eating and mealsroutine of the user is utilized to calculate a forecasted, allowed orexpected ratio of the macronutrients consumed by the user in a day or atleast the allowable glycemic load. A difference between the daily,weekly or monthly expected and actual macronutrient ratio or adifference between the daily, weekly or monthly expected and actualglycemic load may prompt a plurality of recommendations from the HealthManagement application to the user.

Activities information relates to how much and when a person movesaround and/or exercises during the day and utilizes both data input bythe user and data sensed by the one or more sensors 135. The data inputby the user may include details regarding the user's daily activities,for example the fact that the user worked at a desk from 9 a.m. to 5p.m. and then took an aerobics class from 6:30 p.m. to 7:30 p.m.Relevant data sensed by the sensors 135 may include heart rate, movementas sensed by an accelerometer, heat flow, respiration rate, caloriesburned, and galvanic skin response (GSR). Accordingly, calories burnedor spent (calories expenditure) maybe calculated in a variety ofmanners, including: the multiplication of the type of exercise input bythe user by the duration of exercise input by the user; sensed motionmultiplied by time of motion multiplied by a filter constant; and sensedheat flux multiplied by time multiplied by a filter constant or on thebasis of metabolic equivalents (METs). In some embodiments, the user'sRMR (Resting Metabolic Rate) or BMR (Basal Metabolic Rate) is alsocalculated to estimate the amount of calories consumed by the user whichis then used to calculate a daily caloric balance. As known to personsof ordinary skill in the art, RMR or BMR is the rate at which you burnenergy or calories when resting and is a function of at least the user'sage, gender, height and weight. This helps fulfill the basicrequirements of the body to function optimally.

The amount of calories actually consumed by the individual is comparedto the amount of calories expended or burned by the individual fordaily, weekly or monthly periods and is referred to hereinafter asenergy balance of the user. A positive or surplus energy balance isrepresentative of more actual calories consumed in comparison to thecalories expended and is considered to be indicative of a potentialweight gain scenario for the user over a period of time. A negativeenergy balance is representative of less actual calories consumed incomparison to the calories expended and is considered to be indicativeof a potential weight loss scenario for the user over a period of time.

Continuing with various non-limiting examples of the plurality offunctions of the HMA, in various embodiments the HMA also enablespresenting GUI screens to enable the user to record his hunger orappetite profile. Hunger or appetite profile includes data such as thetime of day when the user feels hungry and the intensity of hunger felt.In some embodiments, the intensity of hunger is recorded by the user byselecting from a scale of, for example, 1 to 5, where 1 is indicative oflight hunger and 5 is indicative of very high hunger intensity. Invarious embodiments, the hunger profile includes only those times whenthe user feels hungry but should ideally not consume a meal. This mayinclude, for example, times that do not match the user's standardregular eating and meals profile or routine.

The HMA further enables providing daily feedback from the electro-dermalpatch device to the patient on dietary compliance, calories burned anddisplaying diet plans.

The HMA also enables receiving, processing and analyzing glucose datagenerated by a glucose sensor, included as one of the sensors 135 orconfigured as a third party device in wireless communication with theHMA, in some embodiments. In various embodiments, the glucose data isanalyzed to detect conditions such as a hyperglycemic rush, resultingfrom, for example, a large carbohydrate meal, and titrate stimulation totreat or manage a condition where there is a surplus of insulinsecretion that may trigger hunger in non-diabetic users.

The HMA enables generating and displaying a plurality of charts orgraphs representative of the user's standard regular eating and mealsprofile, actual eating and meals profile, energy balance information,weight trend including a rate of weight loss or gain, glucose data trendand hunger profile over a period of time such as daily, weekly ormonthly.

The HMA enables managing and generating prompts (audio—including actualphone calls, visual and/or tactile) with respect to a plurality ofcompliance aspects such as, but not limited to: stimulation therapycompliance—prompts the user if the user forgets to apply or wear theelectro-dermal patch device and/or disables a recommended duration orfrequency of stimulation therapy; prompts the user with respect to astimulation protocol that a scheduled stimulation is going to begin inthe next T minutes, 10 or 15 minutes for example, and presenting theuser with an option to disable the scheduled stimulation which if notdisabled allows the scheduled stimulation to begin after T minutes;dietary compliance or guidance—the user either selects a predefinedstandard dietary plan (from a drop down list of multiple predefineddietary plans, such as but not limited to Mediterranean Zone diet,Atkins diet, or Jenny Craig) or inputs a customized plan as part of thestandard regular eating and meals routine. The user also records detailsof the actual meals taken and time of meals. Audio, visual and/ortactile alert(s) may be generated, for example, if the user is not incompliance with the selected dietary plan. The compliance prompts areintended to encourage patient compliance and, in some embodiments,include composite scores and displays for overall patient progress.

The HMA enables recommending and/or implementing modification tostimulation patterns or protocols when receiving an input from the userthat the user is encountering a feeling of nausea, dyspepsia, heartburn,or sensation at the stimulation site during and/or after stimulation.

The HMA further enables assessing stimulation habituation, nausea and/ordyspepsia scenarios in the user and accordingly modifying thestimulation patterns or protocols. In various embodiments, these eventsare input into the electro-dermal patch device or companion device bythe patient. For example, in one embodiment, the patient can input, viaa GUI on one or both devices, nausea events, dyspepsia events or hungerevents. The microprocessor then algorithmically processes these eventsand accordingly modifies stimulation.

The HMA enables the remote patient care facility and/or patient carepersonnel to access (via cellular and/or private or public wired orwireless networks such as the Internet) a plurality of user's healthrelated information such as the user's hunger profile, standard eatingand meals profile, actual eating and meals profile, energy balance,weight trends, glucose data and stimulation induced nausea, dyspepsia,habituation events. In some embodiments, the Health Managementapplication periodically transmits the user's health related informationapart from enabling the remote patient care facility and/or patient carepersonnel to access such information in real time or on demand, ifrequired. In various embodiments, the user's authorization is needed toallow such access to the user's health related information.

The HMA also enables detecting removal of the electro-dermal patchdevice—the impedance or bio-impedance electrode enables the HealthManagement application to regularly or continuously monitor electrodeand skin contact impedance. This allows the Health Managementapplication to detect whether the electro-dermal patch device has beenremoved or worn by the user. In some embodiments, where theelectro-dermal patch device is configured for use as a 24/7 wearabledevice, detection of removal of the electro-dermal patch devicecorresponds to missing of the user's health related information.However, in other embodiments, where the electro-dermal patch device isconfigured for use on as-needed or on-demand basis, any missing userhealth related information is treated as non-occurrence of anystimulation event.

The HMA also enables providing unique electrical stimulationcharacteristics and ‘footprints’, based on electrode design andstimulation parameters, allowing the patient to use a variety ofmethodologies for stimulation.

In still a further non-limiting example, the HMA enables providing aweight loss graph along with the patient's pictures corresponding tovarious milestones on the weight loss graph.

In still a further non-limiting example, the HMA enables; enablesbariatric surgeons, doctors, dieticians or medical personnel to tell newpatients about their medical practice.

In still a further non-limiting example, the HMA enables patients tokeep time intervals between meals and fluids. For example, the HMA maynotify users when enough time has passed after drinking to eat and viceversa.

In still further non-limiting examples, the HMA enables patients to viewtheir medical personnel and request an appointment with the office;enables setting of daily reminders for prescribed vitamins andsupplements; enables patients to pose queries to their dietician;enables communicating schedules of weight loss seminars and supportgroups, to the patients; enables medical personnel to communicatehealthy recipes with the patients to support their continued weight losssuccess; enables bariatric surgery patients to stay on track withreminders and a pre-populated checklist—Psych Eval, InsurancePre-approval, Physician Supervised Diet; enables medical personnel aswell as patients to journalize daily thoughts and progress notes;enables information exchange with third party applications; enablespatients to track their water intake along with food consumed; enablesautomatic tracking of calories, protein, fat and carbohydrates consumedby patients; enables scanning of barcodes of package food to allowpatients to see the nutritional information, and have it loggedautomatically to the feed consumed daily diary; enables physicians ormedical personnel to enter specific goals for their patients; enablesphysicians to share their patient status data, with approval from theirpatients, with the fellow practice/department physicians to solicitbetter recommendations for the patients; enables instilling weightmanagement habits in the patients since monitoring of food/caloriesintake leads to better dietary compliance; enables physicians,dieticians and other medical personnel to send out push notifications totheir patients to keep the patients engaged and motivated towards theirhealth goals.

It should be appreciated that in various embodiments, the user'splurality of health related information is utilized by the HealthManagement application to suggest and/or implement a plurality ofrecommendations comprising stimulation patterns or protocols, medication(such as an amount of insulin intake, for example), dietary and/oractivities plans. For example, if the user's actual calories consumptionis found to be higher than the expected calories consumption,consistently over a period of time, the Health Management applicationmay recommend any one or a combination of: a specific standard diet planto the user; a change from a first standard diet plan to a secondstandard diet plan or prescribe customization of an existing standarddiet plan that the user may be following; recommend or change anexisting stimulation protocol to suppress the user's appetite and/orsuggest to the user to increase his activity levels such as walking,exercising.

In some embodiments, the plurality of recommendations is auto generatedby the Health Management application and presented to the user for hisauthorization for implementation. In some embodiments, the plurality ofrecommendations auto generated by the Health Management application arepresented to the remote patient care facility and/or personnel forauthorization or approval and thereafter either implemented or presentedagain to the user for a final authorization for implementation. In someembodiments, the Health Management application receives a plurality ofrecommendations prescribed by the remote patient care facility and/orpersonnel based on the user's plurality of health related information.

In various embodiments, the user is presented, on one or more GUIs, aplurality of recommendations, which are auto generated by the HealthManagement application as well as those received as prescriptions orrecommendations from the remote patient care facility or personnel, thereasons for each of the plurality of recommendations,authorizations/approvals or disapprovals against each of the pluralityof recommendations as received from the remote patient care facility orpersonnel, and annotations or notes from the remote patient carefacility or personnel describing reasons for approving or disapprovingeach of the plurality of recommendations that were generated by theHealth Management application. The user then reviews andauthorizes/approves or disapproves implementation of each of theplurality of recommendations. In some embodiments, however,authorizations to implement the plurality of recommendations may not berequired from the user and/or the remote patient care facility orpersonnel. For example, in one embodiment wherein the electro-dermalpatch device is worn 24 hours per day, the number of stimulationsessions per a specified time period is automatically titrated up ordown based on the recommendations. In another embodiment, the durationof stimulation is automatically titrated up or down based on therecommendations. In other embodiments, other stimulation parameters arechanged automatically based on the recommendations.

In various embodiments, the companion device includes a ‘diary’ for thepatient to input, track, record, and display patient parameters. FIG. 7is a screen shot of a companion device depicting a diary widget 705, inaccordance with one embodiment of the present specification. The diarywidget 705 includes icons enabling the patient to input and view entriesin the diary. The diary widget 705 includes a quick entry buttons icon706 which, when pressed, causes the companion device to display buttonsfor making diary entries. The diary widget 705 also includes a list viewof diary entries icon 707 which, when pressed, causes the companiondevice to display the diary in a list format. The diary widget 705 alsoincludes a calendar view of diary entries icon 708 which, when pressed,causes the companion device to display the diary in a calendar format.

FIG. 8 is a screen shot of a companion device depicting a list view ofdiary entries 805, in accordance with one embodiment of the presentspecification. The list view of diary entries 805 is accessed bypressing the list view of diary entries icon 707 as shown on FIG. 7. Invarious embodiments, the list view of diary entries 805 displays entriesinput by the patient for instances such as stimulation sessions 806 andpatient parameters, for example, hunger 807 and appetite 808. Thestimulation session entry 806 displays the time 816 of the entry anddetails 826 of the stimulation session. Each patient parameter entry807, 808 displays the time 817, 818 of the entry, the type of parameter837, 838, and a score with description 827, 828 associated with theentry. The list view of diary entries 805 also displays the date 803 andthe name of the diary 802 being viewed.

FIG. 9 is a screen shot of a companion device depicting a calendar viewof diary entries 905, in accordance with one embodiment of the presentspecification. The calendar view of diary entries 905 is accessed bypressing the calendar view of diary entries icon 708 as shown on FIG. 7.The calendar view of diary entries 905 displays the days 906 of themonth being viewed. Pressing on an individual day displays the diaryentries for that day as a list 907. The patient can scroll through thelist 907 to view entries. The calendar view of diary entries 905 alsodisplays the month and year 903 and the name of the diary 902 beingviewed.

FIG. 10 is a screen shot of a companion device depicting a quick entrybuttons view 1005, in accordance with one embodiment of the presentspecification. The quick entry buttons view 1005 is accessed by pressingthe quick entry buttons icon 706 as shown on FIG. 7. In one embodiment,the quick entry buttons view 1005 includes six quick entry buttons:appetite 1006, exercise 1007, hunger 1008, stim (that is, stimulation)sessions 1009, weight 1010, and well-being 1011. The quick entry buttonsdepicted in FIG. 10 are exemplary only and not intended to be limiting.In other embodiments, fewer or additional quick entry buttons areincluded on the quick entry buttons view. Pressing on any one of thequick entry buttons 1006, 1007, 1008, 1009, 1010, 1011 causes thecompanion device to display an entry screen for the chosen button. Thequick entry button view 1005 also displays the name of the diary 1002being viewed.

FIG. 11 is a screen shot of a companion device depicting an appetiteentry screen 1105, in accordance with one embodiment of the presentspecification. The appetite entry screen 1105 allows the user to enterthe type 1106 and item 1107 of patient parameter, in this case appetite,and a score 1108 associated with the parameter. The score 1108 has anumerical value 1109 and a description 1110 associated therewith to helpthe patient determine which score best fits the current parameter. Insome embodiments, for appetite, the description relates to how much thepatient ate compared to the amount recommended by the patient's diet. Insome embodiments, the score ranges from 1 to 5. The appetite entryscreen 1105 also displays the time and date 1103 the entry is beingentered and the name of the diary 1102. The patient can save the entryby pressing the disk icon 1101 or cancel the entry by pressing the Xicon 1104.

FIG. 12 is a screen shot of a companion device depicting an exerciseentry screen 1205, in accordance with one embodiment of the presentspecification. The exercise entry screen 1205 allows the user to enterthe type 1206 and item 1207 of patient parameter, in this case exercise,and a score 1208 associated with the parameter. The score 1208 has anumerical value 1209 and a description 1210 associated therewith to helpthe patient determine which score best fits the current parameter. Insome embodiments, for exercise, the description relates to how manysteps the patient took per day. In some embodiments, the score rangesfrom 1 to 5. The exercise entry screen 1205 also displays the time anddate 1203 the entry is being entered and the name of the diary 1202. Thepatient can save the entry by pressing the disk icon 1201 or cancel theentry by pressing the X icon 1204.

FIG. 13 is a screen shot of a companion device depicting a hunger entryscreen 1305, in accordance with one embodiment of the presentspecification. The hunger entry screen 1305 allows the user to enter thetype 1306 and item 1307 of patient parameter, in this case hunger, and ascore 1308 associated with the parameter. The score 1308 has a numericalvalue 1309 and a description 1310 associated therewith to help thepatient determine which score best fits the current parameter. In someembodiments, for hunger, the description relates to the level of hungerthe patient is experiencing. In some embodiments, the score ranges from1 to 5. The hunger entry screen 1305 also displays the time and date1303 the entry is being entered and the name of the diary 1302. Thepatient can save the entry by pressing the disk icon 1301 or cancel theentry by pressing the X icon 1304.

FIG. 14 is a screen shot of a companion device depicting a stimulationsession entry screen 1405, in accordance with one embodiment of thepresent specification. The stimulation session entry screen 1405 allowsthe user to enter the type 1406 and item 1407 of session, in this case astimulation session, and a level 1408 associated with the session. Thelevel 1408 has a numerical value 1409 and a description 1410 associatedtherewith to help the patient determine which level best represents whatwas applied during the current session. In some embodiments, forstimulation session, the description relates to how often stimulationwas delivered per day and for how long the stimulation was appliedduring each session. In some embodiments, the level ranges from 1 to 4.The stimulation session entry screen 1405 also displays the time anddate 1403 the entry is being entered and the name of the diary 1402. Thepatient can save the entry by pressing the disk icon 1401 or cancel theentry by pressing the X icon 1404.

FIG. 15 is a screen shot of a companion device depicting a weight entryscreen 1505, in accordance with one embodiment of the presentspecification. The weight entry screen 1505 allows the user to enter thetype 1506 and item 1507 of patient parameter, in this case weight, and aweight in pounds 1508 associated with the parameter. The weight entryscreen 1505 includes a numeric keypad 1509 for the patient to use toenter the weight. The weight entry screen 1505 also displays the timeand date 1503 the entry is being entered and the name of the diary 1502.The patient can save the entry by pressing the disk icon 1501 or cancelthe entry by pressing the X icon 1504.

FIG. 16 is a screen shot of a companion device depicting a well-beingentry screen 1605, in accordance with one embodiment of the presentspecification. The well-being entry screen 1605 allows the user to enterthe type 1606 and item 1607 of patient parameter, in this well-being,and a score 1608 associated with the parameter. The score 1608 has anumerical value 1609 and a description 1610 associated therewith to helpthe patient determine which score best fits the current parameter. Insome embodiments, for well-being, the description relates to a level ofnausea, dyspepsia and/or abdominal discomfort the patient isexperiencing. In some embodiments, the score ranges from 1 to 3. Thewell-being entry screen 1605 also displays the time and date 1603 theentry is being entered and the name of the diary 1602. The patient cansave the entry by pressing the disk icon 1601 or cancel the entry bypressing the ‘X’ icon 1604.

It should be appreciated that, in some embodiments, the HMA incorporatesGUIs that present scales, surveys, or questionnaires designed toquantitatively assess one or more of a person's appetite, hunger, levelof satiety, level of satiation, level of fullness, level of well-being,level of nausea, feelings of pain, level of dyspepsia, perception offood, and changes thereto.

For example, SNAQ (Simplified Nutritional Appetite Questionnaire) is anappetite assessment tool that predicts weight loss. SNAQ includesquestions that rank, on a scale of 1 to 5, the strength of appetite,feelings of fullness after eating, taste of food and number of mealseaten each day. A SNAQ score of less than or equal to 14 predicts highlikelihood of at least 5% weight loss within six months. The GhrelinHunger Scale (G-scale) is a two dimensional scale wherein a first scaleof 1 to 7 on the y-axis is used to assess the feeling of hunger/fullnessand a second scale of 1 to 7 on the x-axis is used to assess the timeelapsed since a last meal (breakfast, lunch, snack, or dinner).

In general, each such scale is a form of a visual analog scale (VAS). AVAS is question-based assessment mechanism, where a visual measure isassociated with each question and where answering the question requiresselecting a quantifiable position within that visual measure, indicativeof a particular level or degree. The scale is typically composed oflines (of varying length) with words anchored at each end, describingthe extremes (that is, ‘I am not hungry at all’ on the left to ‘I havenever been more hungry’ on the right). Patients are asked to make a markacross the line corresponding to their feelings. Quantification of themeasurement is done by measuring the distance from the left end of theline to the mark. In some embodiments, VAS may be used to assesssensations of pain (due to stimulation, for example), hunger, appetite,satiation, fullness, satiety, overall quality of life, degree of nausea,degree of well-being, degree of dyspepsia, perception of food, foodaversions, and perceptions of dietary compliance. In accordance withsome aspects of the present specification, the users are provided withGUIs to activate VAS based light or progress bars to enable the users torecord parameters such as the level of hunger, appetite and well-being.

FIG. 35A illustrates a VAS questionnaire 3505 for assessing hungersensations or appetite. The questionnaire 3505 presents a patient with aleading question, such as, “how hungry do you feel?” while the twoextremities 3506, 3507 of the scale line 3508 are anchored with wordsthat describe the feeling of least and maximum hunger. In one embodimentthe two extremities 3506, 3507 are described as “I am not hungry at all”and “I have never been more hungry”, respectively.

FIG. 35B illustrates a VAS questionnaire 3510 for assessing a feeling offullness. The questionnaire 3510 presents the patient with a leadingquestion, such as, “how full do you feel?” while the two extremities3511, 3512 of the scale line 3513 are anchored with words that describethe feeling of least and maximum fullness. In one embodiment the twoextremities 3511, 3512 are described as “Not at all full” and “Totallyfull”, respectively.

FIG. 35C illustrates a VAS questionnaire 3515 for assessing a feeling ofsatiation. The questionnaire 3515 presents the patient with a leadingquestion, such as, “how satisfied do you feel?” while the twoextremities 3516, 3517 of the scale line 3518 are anchored with wordsthat describe the feeling of least and maximum satiation. In oneembodiment the two extremities 3516, 3517 are described as “I amcompletely empty” and “I cannot eat another bite”, respectively.

FIG. 35D illustrates a VAS questionnaire 3520 for assessing a feeling ofsatiety. The questionnaire 3520 presents the patient with a leadingquestion, such as, “how much do you think you can eat?” while the twoextremities 3521, 3522 of the scale line 3523 are anchored with wordsthat describe the feeling of least and maximum satiety. In oneembodiment, the two extremities 3521, 3522 are described as “A lot” and“Nothing at all”, respectively.

Persons of ordinary skill in the art should appreciate that the leadingquestion and anchoring words at the two extremities of the scale, foreach questionnaire of FIG. 35A through 35D, may be linguisticallymodified in alternate embodiments without departing from the assessmentobjective or the feeling to be assessed. For example, in an alternateembodiment the questionnaire 3520 the leading question is “How strong isyour desire to eat now?” while the two extremities 3521, 3522 aredescribed as “Extremely” and “Not at all”. Additionally, otherintermediate language may be used between the two extremes.

In various alternate embodiments, GUIs showing VAS questionnaires can bedesigned to assess aspects such as, but not limited to, health-relatedoverall quality of life, degree of nausea, degree of pain felt, degreeof well-being, and degree of dyspepsia. For example, in one embodiment,to assess nausea levels a VAS questionnaire may present a leadingquestion, such as, “Do you feel nauseous?” while the two extremities ofthe scale are described as “A lot” and “Not at all”. In anotherembodiment, to assess health-related overall quality of life or degreeof well-being a VAS questionnaire may present a leading question, suchas, “How satisfied are you with your health as whole?” with the twoextremities of the scale being described as “completely dissatisfied”and “completely satisfied”. In yet another embodiment, to assess degreeof dyspepsia a VAS questionnaire may present a leading question, suchas, “Has your ability to eat or drink (including when, what, and howmuch) been disturbed by your stomach problems in the last 2 weeks?” withthe two extremities of the scale being described as “Extremely” and “Notat all”. In still another embodiment, to assess bowel movements, a VASquestionnaire may present a plurality of leading questions to assesstiming of bowel movement, whether the bowel movements are emergencies ornot, frequency and/or amount of defecation.

In some embodiments, as described above, the VAS is configured as aquestionnaire with each question representative of a quantifiableposition (or number such as, for example, 1,2,3,4 or 5 on a VAS scaleranging from 1 to 5) within the visual measure that is indicative of aparticular level, intensity or degree. In some alternate embodiments,the VAS is configured as a spectrum of colors wherein each color of thespectrum is quantifiable (optionally, in the form of a number) toindicate a particular level, intensity or degree. FIG. 76 illustrates ahunger or appetite VAS scale 7600 configured as a color spectrum whereineach color, when chosen by the user, is quantified into a number andrepresentative of an intensity of hunger or appetite. As an example, thescale 7600 ranges from light green, dark green, yellow, orange to redpositions corresponding to an intensity ranging from 1 to 5 such thatlight green (quantifiable as 1) represents a lowest intensity ofhunger/appetite whereas red (quantifiable as 5) represents a highestintensity of hunger/appetite. The scale may vary in differentembodiments, for example instead of the color spectrum representing thescale of 1 to 5 a color spectrum may represent a scale of 1 to 10. Thus,a VAS can be displayed as a questionnaire, number and/or color spectrum,in various embodiments.

In various embodiments, the HMA presents GUIs to enable the user torecord daily diary recordings of: timing, duration and amplitude ofplanned or scheduled stimulation sessions; timing, duration andamplitude of on-demand or rescue boluses (as described later in thisspecification); amount and type of calories consumed per day; hungerbased on, for example, an aggregation of rescue boluses and/or VAShunger scale entries whenever the user is hungry; user's weight;calories burned based on, for example, steps taken; daily quality oflife and/or nausea/dyspepsia entry on VAS.

As discussed earlier, the Health Management application is capable ofcommunicating (via pairing or syncing) with a third party device(including a third party application software on an external device),with physiological sensors, configured to be worn on the human body,such as around the wrist (as a smart watch, for example), or the feet(as smart shoes, for example, that utilize a plurality of sensors, totrack and record physiological data associated with running such as, butnot limited to, cadence, steps taken, calories burned, duration of run,pace, heart rate), in order to monitor, acquire, record, and/or transmitthe physiological data, to receive and integrate exercise or caloriesexpended and weight loss information, along with one or moreelectro-dermal patch devices of the present specification.

In some embodiments, the third party device enables diet monitoring (interms of amount and type or quality of calories consumed) andcommunicates dietary information to the HMA for display to the user onhis companion device, for example. In various embodiments, the user'sdietary information (received from a third party device and/orapplication) alone or in tandem with the user's daily diary informationis/are used to titrate stimulation therapy. In embodiments, the thirdparty device is a WIFI or Bluetooth enabled bathroom weighing scale tocapture daily weight and automatically input this data into the user'sdaily diary. In embodiments, the third party device is an exercisemonitoring wearable device, such as a smart watch, that communicatesexercise or fitness information (such as, but not limited to, stepstaken, heart rate) to the HMA for display on the user's companiondevice. The exercise or fitness information is utilized by the HMA toalso titrate stimulation therapy.

It should be appreciated that the third party device, whether it is athird party application software on an external device or a secondexternal device entirely (such as, but not limited to, a watch, a pairof smart shoes, a diabetes wearable pump, or another medical device), isenabled to obtain information from the EDP device of the presentspecification, either directly from the EDP device, directly from theHealth Management application, or directly from a server in datacommunication with the EDP device or the Heath Management application ofthe present specification. In some embodiments, the user's daily diaryinformation such as, but not limited to, appetite score can be displayedon the user's third party device such as the smart watch. Consequently,the third party application or the second external device can displayany information gathered by the EDP device and/or Health Managementapplication, including patient diary inputs, the patient's level ofhunger, the patient's level of wellbeing, the patient's level ofappetite, the stimulation settings, or an aggregate/composite weightmanagement performance score which aggregates any of the data tracked bythe third party device with any of the data tracked by the EDP deviceand/or Health Management application to yield a single composite score.

In some embodiments, the HMA prompts the user to click her selfie orphoto—indicative of the user's input of her health status comprisingcurrent body outline, contour, shape and size. In some embodiments, theselfie is body part specific such as that of the face, torso and/orbutt). In embodiments, the user's selfie is processed and stored, by theHMA, as an avatar or graphical representation of the user. Inembodiments, the HMA prompts the user to click and input her selfie atpredetermined intervals of time, such as every day, alternate days,twice or thrice a week, for example, during the course of thestimulation treatment. If the user's health goal is to lose weight, theevolving avatars, selfies or photo records (during the course of thestimulation therapy), periodically acquired and stored by the HMA, areanalyzed to determine if the user's body outline is changing compared toan ideal or target body outline, shape (at the user's target weightgoal, for example) and/or compared to the body outline at the beginningor during earlier periods of the therapy. The user's evolved bodyoutline, shape and size is displayed with a comparison to the user'sbody outline prior to commencement of the stimulation therapy and/oragainst an ideal or target body outline and shape. Such a comparativedisplay serves to provide to the user an evolving long term healthperformance record. In various embodiments, the user can have herevolved avatar printed on her clothes and displayed as a display pictureon her communication networks or channels such as, but not limited to,social media networks, affinity groups, Facebook, and WhatsApp.

In various embodiments, the Health Management application of the presentspecification interrogates the user (using GUIs of VAS questionnaires,for example or through voice-based inputs using an Intelligent PersonalAssistant as described later in the specification) at the end of eachday, at a time convenient and chosen by the user, about his dailywell-being. In some embodiments, VAS questionnaires are directed towardsat least, but not limited to, the user's satisfaction with hishunger/appetite management for the day, dietary compliance for the dayand overall well-being level for the day. The HMA also automaticallydownloads health or fitness related information from third party deviceseach day, and preferably at the end of the day. In some embodiments, theHMA prompts the user to record his weight at least once in a week (ormore frequently, such as daily, in alternate embodiments). Inembodiments, the HMA generates automated feedback or advice based on aplurality of user's aggregated health related information such as, butnot limited to, the daily inputs recorded for the VAS questionnaires,daily fitness related information (such as, steps taken for example)from third party devices, general compliance such as wearing the EDPdevice to stimulate as per scheduled protocol, daily rescue boluses andthe daily or weekly weight measurements. In some embodiments, theautomated feedback is delivered to the user through an IntelligentPersonal Assistant (IPA) as described later in this specification.

In some embodiments, the Health Management application of the presentspecification may be directly installed or implemented on a third partydevice, such as a wristwatch, via a download from a remote server. Insuch embodiments, the Health Management application is configured forcompatibility and use on such third party devices. Accordingly, apartfrom displaying any information gathered by the EDP device and/or HealthManagement application, the third party device can also be used by theuser to manage titration or setting of stimulation parameters, includingpatient diary inputs. Such embodiment would obviate a need for aseparate companion device.

The third party device, in various embodiments, may track one or anycombination of the following patient related data: heart rate, pulserate, beat-to-beat heart variability, EKG or ECG, respiration rate, skintemperature, core body temperature, heat flow off the body, galvanicskin response or GSR, EMG, EEG, EOG, blood pressure, body fat, hydrationlevel, activity level, oxygen consumption, glucose or blood sugar level,body position, pressure on muscles or bones, and/or UV radiationexposure and absorption or any other parameter listed in Tables 1 andTable 2 above, data representative of the air quality, soundlevel/quality, light quality or ambient temperature near the patient, orthe global positioning of the patient, patient's weight, food consumed,type and amount of activity or exercise (such as steps take, swimming,running).

In accordance with an aspect of the present specification, the HMA isenabled for communicating or interfacing with and operating or drivingan Intelligent Personal Assistant (hereinafter also referred to as IPA)system. In embodiments, the IPA system is capable of accepting andprocessing a user's voice based inputs and performing a plurality oftasks or services, based on the user's voice based inputs or commands,including providing to the user voice based outputs such as, but notlimited to, alerts, reminders, information or prompts. In accordancewith various aspects of the present specification, the IPA system isdesigned to simulate a conversation with one or more human users viaauditory methods. The IPA system may also be referred to as a chatrobot, chatter robot, chatterbot, chatbot or chat bot, ArtificialConversational Entities (ACEs), Artificial Intelligence Agent (AIA),talk bot, and/or chatterbox. In some embodiments, the IPA systemcomprises an IPA device running an IPA software application. In someembodiments, the IPA system is implemented as a client-serverarchitecture wherein the IPA device (client) is in communication with anIPA server. In such embodiments, the IPA software application isimplemented as a client component residing on the IPA device and aserver component residing on the IPA server. Alternately, the IPAsoftware application may be implemented only on the IPA server side.

In various embodiments, the IPA device is a hand-held or portablecomputing device capable of accepting voice based inputs (using one ormore microphones), generating voice based outputs (using one or morespeakers) and capable of accessing a cellular, Internet, TCP/IP,Ethernet, Bluetooth, wired, or wireless network. Examples of suchportable computing devices include, but are not limited to, smartphones,tablets, speakers, or PDAs.

FIG. 48A is a block diagram illustration of the HMA, of the presentspecification, integrated and in communication with an IPA system, inaccordance with an exemplary embodiment. In this embodiment, the HMA isimplemented, as a client side software component, on a companion device4805 (similar to the companion device 105 of FIG. 1A) which is in datacommunication with at least one EDP device 4810 of the presentspecification. The companion device 4805 is also in communication, vianetwork 4825, with a health management server 4815, that implements aserver side software component of the HMA, and optionally a remotepatient care facility and/or patient care personnel. The network 4825 isa cellular, Internet, TCP/IP, Ethernet, Bluetooth, wired, or wirelessnetwork. In accordance with an embodiment, the companion device 4805,and therefore the HMA client component, is further in data communicationwith an IPA device 4830 that implements a client side software componentof the IPA software application. The IPA device 4830 is also incommunication, via the network 4825, with an IPA server 4835 thatimplements a server side software component of the IPA softwareapplication. It should be appreciated that the companion device 4805 maybe in data communication with the at least one EDP device 4810 and theIPA device 4830 through a direct wired or wireless link such as WiFi orBluetooth, via pairing or syncing for example, or through the network4825. Similarly, the health management server 4815 and the IPA server4835 are also capable of being in data communication with each otherthrough network 4825. Thus, in this embodiment, the IPA system comprisesa standalone IPA device 4830 separate from the companion device 4805. Inother words, the IPA and HMA software applications are installed orimplemented on separate devices.

FIG. 48B is a block diagram illustration of the HMA, of the presentspecification, integrated and in communication with the IPA system, inaccordance with another exemplary embodiment. In this embodiment, theHMA as well as the IPA software application are installed orimplemented, as client side software components, on the companion device4805 which is in data communication with at least one EDP device 4810 ofthe present specification. The client side HMA and IPA softwarecomponents, on the companion device 4805, are in data communication witheach other. The IPA software component, on the companion device 4805,may or may not be in direct communication with the at least one EDPdevice 4810. The companion device 4805 is also in communication, vianetwork 4825, with the health management server 4815 that implements theserver side software component of the HMA, the IPA server 4835 thatimplements the server side software component of the IPA softwareapplication and optionally a remote patient care facility and/or patientcare personnel. The network 4825 is a cellular, Internet, TCP/IP,Ethernet, Bluetooth, wired, or wireless network. Also, the healthmanagement server 4815 and the IPA server 4835 are capable of being indata communication with each other through network 4825. Thus, in thisembodiment, the IPA system does not comprise a standalone IPA device4830 separate from the companion device 4805. In other words, the IPAand HMA software applications are installed or implemented on the sameclient side devices, that is, the companion device 4805.

During operation the HMA communicates with the IPA system to enablevoice based interfacing with the user. Thus, the voice enabled interfaceof the IPA system augments or replaces the plurality of GUIs andassociated functionalities implemented by the HMA of the presentspecification. Referring now to FIGS. 48A and 48B, in variousembodiments, the user's voice based inputs, commands, instructionsand/or queries (collectively also referred to as ‘inputs’) are receivedby the client side IPA software component—residing on the companiondevice 4805 (along with the client side HMA software component) orseparately on the IPA device 4830. The client side IPA softwarecomponent, in some embodiments, may stream the user's voice based inputsto the IPA server 4835, via network 4825, for further processing andthereafter communication to the HMA server 4815 and/or the client sideHMA software component residing on the companion device 4805. In otherembodiments, the client side IPA software component may itself processthe user's voice based inputs and thereafter communicate with the HMAserver 4815 and/or the client side HMA software component residing onthe companion device 4805.

In accordance with various aspects, the IPA system processes the user'svoice based inputs to derive input programmatic instructions that arecommunicated to the HMA for a plurality of health management relatedactions associated with the EDP device 4810 of the presentspecification. Similarly, output programmatic instructions associatedwith a plurality of prompts, alerts, reminders, instructions or statusreports (collectively also referred to as ‘outputs’) generated by theHMA are communicated by the companion device 4805 and/or the HMA server4815 to the IPA device 4830 and/or the IPA server 4835. In accordancewith various aspects, the IPA system processes these output programmaticinstructions to convert them into voice based outputs that arecommunicated to the user as information and/or for further user actions.

In accordance with some embodiments, the HMA shares, with the IPAsystem, a plurality of the user's (and/or social network aggregated)health related information such as the user's hunger profile, standardeating and meals profile, actual eating and meals profile, energybalance, weight trends, glucose data and stimulation induced nausea,dyspepsia, habituation events. In some embodiments, the HMA periodicallytransmits the user's health related information apart from enabling theIPA system to access such information in real time or on demand, ifrequired. In various embodiments, the user's authorization is needed toallow such access to the user's health related information.

The HMA in communication with the IPA system enables receiving from andproviding to the user, voice based inputs and outputs associated with aplurality of functions enabled by the HMA, non-limiting examples ofwhich are described henceforth.

The HMA in communication with the IPA system, enables voice basedcommunication to the user that the HMA (companion device 4805) issuccessfully linked (via pairing or syncing, for example) with the EDPdevice 4810 including announcements related to battery life of the EDPdevice 4810.

The HMA in communication with the IPA system, enables voice basedcommunication to the user indicating that a) the EDP device 4810 hasbeen properly placed on the user's body, b) the one or more electrodesof the EDP device 4810 is aged and needs to be replaced.

The HMA in communication with the IPA system, enables voice basedcommunication to the user indicating whether the EDP device 4810 hasbeen placed at an appropriate location, such as the T2-T12 and/or C5-T1dermatomes for eating disorders.

The HMA in communication with the IPA system, enables voice basedcommunication by the user to the HMA that the user needs to administerstimulation therapy on-demand. Additionally, the HMA in communicationwith the IPA system enables voice based instructions or commands by theuser to select, set and/or modify a plurality of stimulation parameters,settings or protocol therapies.

The HMA in communication with the IPA system, enables voice basedcommunication prompting the user to stimulate based upon time of day,historical trends in appetite, caloric intake, and exercise data.

The HMA in communication with the IPA system, enables voice basedcommunication to the user regarding effectiveness of a stimulationduring a stimulation therapy. This includes announcing to the user,recommended adjustments or modifications to a plurality of stimulationparameters. In some embodiments, the recommended adjustments to theplurality of stimulation parameters must be accepted or authorized forimplementation by the user through voice based acceptances.

The HMA in communication with the IPA system, enables voice basednotification to the user when enough time has passed after drinking toeat and vice versa.

The HMA in communication with the IPA system enables voice based userinputs regarding his current weight per day. Voice based communicationto the user includes current stimulation parameters and other real-timeinputs, such as diary and exercise monitoring.

The HMA in communication with the IPA system enables voice based userinputs such as, but not limited to, eating information and activitiesinformation. The eating information includes standard regular eating andmeals profile of the user (representing the general eating habit of theuser) as well as real time actual eating and meals profile of the usersuch as the actual time of consumption of a meal in a day and the actualtype and amount of food eaten at the meal.

The HMA in communication with the IPA system enables voice basedcommunication to the user regarding the difference between the user'sdaily, weekly or monthly expected and actual calories consumption valueincluding a plurality of recommendations (by the HMA) resulting from thecalculated difference. Voice enabled user communication also includesannouncing the amount of extra macronutrients, such as carbs, proteinand fats, and/or glycemic load consumed compared to an acceptable amountof macronutrients allowed based on a standard diet plan being followedby the user, including the effect such extra consumption will have onthe user's weight loss goal, for example.

The HMA in communication with the IPA system enables voice based userinputs regarding activities information such as how much and when theuser moves around and/or exercises during the day.

The HMA in communication with the IPA system enables voice basedcommunication to the user if he is at a positive or negative energybalance. Such communication may be triggered by the user's voice basedqueries asking for his energy balance status for the day or for hisaverage weekly or monthly energy balance. The HMA in communication withthe IPA system also enables voice based reporting to the user (based onthe user's voice based queries, for example) regarding the user'sstandard regular eating and meals profile, actual eating and mealsprofile, weight trend including a rate of weight loss or gain, glucosedata trend and hunger profile over a period of time such as daily,weekly or monthly.

The HMA in communication with the IPA system enables voice based userinputs regarding his hunger or appetite profile.

The HMA in communication with the IPA system enables voice basedcommunication with one or more third party service providers for useractivated or automated ordering of accessories, such as electrodepatches for example; standard meals, such as Jenny Craig, or fitnesscoaching services. HMA's enablement of communication with one or morethird party service providers, via the IPA system, also allows forsourcing and paying for online services and/or for advertising.

The HMA in communication with the IPA system enables voice basedfeedback to the user on dietary compliance, calories burned, diet plansand detected conditions such as a hyperglycemic rush. The HMA incommunication with the IPA system also enables voice based prompts tothe user with respect to a plurality of compliance aspects such as, butnot limited to: stimulation therapy compliance—generating voice basedprompts if the user forgets to apply the electro-dermal patch deviceand/or disables a recommended duration or frequency of stimulationtherapy; generating voice based prompts to the user with respect to astimulation protocol that a scheduled stimulation is going to begin inthe next T minutes, 10 minutes for example, and asking the user with anoption to disable the scheduled stimulation which if not disabled allowsthe scheduled stimulation to begin after T minutes; dietary complianceor guidance—the user either selects, using interactive voice basedinputs, a predefined standard dietary plan or inputs a customized planas part of the standard regular eating and meals routine. The user alsorecords, using interactive voice based inputs, details of the actualmeals taken and time of meals. Voice based alert(s) may be generated,for example, if the user is not in compliance with the selected dietaryplan. The voice enabled compliance prompts are intended to encourageuser compliance and, in some embodiments, include announcing compositescores and overall patient progress.

With reference to FIG. 48A, for example, the IPA device 4830 may includea sensor to detect proximity of the EDP device 4810. The IPA device 4830may be, for example, stationed in the user's kitchen. When the user,wearing the EDP device 4810, enters the kitchen the IPA device 4830detects the user's presence and, in real-time or near real-time,communicates the user's presence in the kitchen to the companion device4805. The HMA, on the companion device 4805, processes the user's visitto the kitchen (assuming the user's visit to the kitchen is likely tolead to an eating event based on the user's past eating records) inlight of at least the user's current energy balance and standard dietplan to determine if the user should or should not eat. If the user'senergy balance is positive and/or the user's consumption of a meal, as aresult of the visit to the kitchen, is unscheduled and not in line withthe standard diet plan—the HMA generates an alert. The alert, in someembodiments, is communicated to the IPA system as a result of which theIPA device 4830, in the kitchen, provides a voice based alert to theuser dissuading him from consuming an unscheduled meal. In alternateembodiments, the HMA alert results in triggering the EDP device 4810 tostart a therapeutic stimulation or a short and low amplitude cautionarystimulation pulse.

However, if the user visits the kitchen near meal time, the IPA device4830, in the kitchen, may ask the user what he is eating or planning toeat. Depending on the user's response, the IPA system may breakdown thepotential amount and types of calories for the food the user is eatingor about to eat and recommend healthier food options to the user besidesproviding advice on the amount of serving of the food that the user mayconsume, for example. In various other embodiments, the IPA systemintegrates the user's hunger level, profile and timing with the IPAsystem's knowledge of the user's kitchen inventory to proactively advicethe user on what to eat and make recommendations (such as, how much ofwhat food to eat, and what to avoid) knowing that the user is hungry orlikely to be hungry around a certain time. Such IPA system basedproactive recommendations on food consumption, starting of a therapeuticstimulation or a short and low amplitude cautionary stimulation pulsecould be triggered based on various combinations of events such as, butnot limited to, the user leaving the house or based on a certain time ofday when the user feels out-of-time snacking pangs, for example.

In accordance with another aspect, the IPA system responds differentlydepending at least upon the time of day when the user verbally conveysto the IPA system that he is hungry. For example, if the user indicateshunger at a mealtime, the HMA in communication with the IPA system mayrecommend healthy recipes and/or offer to order food from variousrestaurants. However, if the user indicates hunger past standard orscheduled mealtimes the HMA in communication with the IPA system maysend a signal to Bluetooth activated locks that would lock pantry orterminate functionality of kitchen appliances (using wirelesscommunication).

The HMA in communication with the IPA system enables voice based userinputs related to feeling of nausea, dyspepsia, heartburn, or sensationat the stimulation site during and/or after stimulation.

The HMA in communication with the IPA system enables voice based alertsto the user in case of removal of the EDP device 4810 from the user'sbody.

In embodiments where the Health Management application implements aneating moment recognition method (FIG. 58) and is also in communicationwith the IPA system, identification or determination of an eating momentor activity by the HMA is communicated to the IPA system that mayconsequently deliver auditory prompts to the user enquiring if the useris indeed eating and if yes, then cautioning the user if the eatingevent is unscheduled or not in line with a meal regimen being followedby the user, for example. In some embodiments, the eating momentrecognition method is implemented directly by the IPA device which maybe in direct communication with the EDP device 4810. In someembodiments, the EDP device 4810 is configured as a band or wristwatch(such as the band 2105 of FIG. 21A or the wristwatch 2106 of FIG. 21B)and includes an accelerometer to detect, capture and acquire a pluralityof dietary data related to physical body movements, such as (forexample) haptic motions of the wrist or hand, of the user involved infood intake gestures. In such embodiments, dietary data from the EDPdevice (wristwatch or band) is communicated directly to the IPA device(in communication with the wristwatch or band) for detecting eatingevents or activities to issue appropriate auditory prompts orconversation to the user.

In still further non-limiting examples, the HMA in communication withthe IPA system enables: voice based setting, by the user, of dailyreminders for prescribed vitamins and supplements; enables users to posevoice based queries to their dietician; enables voice basedannouncements of schedules of weight loss seminars and support groups,to the user; enables medical personnel to communicate healthy recipeswith the user to support their continued weight loss success; enablesbariatric surgery patients to stay on track with voice enabled remindersand review of pre-populated checklist—Psych Eval, InsurancePre-approval, Physician Supervised Diet; enables medical personnel aswell as users to dictate daily thoughts and progress notes; enables ordisables information exchange with third party applications by allowingthe user to provide voice enabled commands; enables the user to receivevoice based status reports related to tracked calories, protein, fat andcarbohydrates consumed by the user; enables scanning of barcodes ofpackage food to allow users to listen to the nutritional information,and have it logged automatically to the feed consumed daily diary byissuing voice based commands; enables instilling weight managementhabits in the patients since voice enabled prompts related tofood/calories intake leads to better dietary compliance; enablesphysicians, dieticians and other medical personnel to send out voicebased push notifications to their users to keep the users engaged andmotivated towards their health goals.

As discussed earlier in this specification, the user's plurality ofhealth related information is utilized by the HMA to suggest and/orimplement a plurality of recommendations comprising stimulation patternsor protocols, medication (such as an amount of insulin intake, forexample), dietary and/or activities plans. In some embodiments, theplurality of recommendations are announced to the user for his voiceenabled authorization for implementation.

In yet further non-limiting examples, the HMA in communication with theIPA system enables delivering voice based prompts to the user andreceiving voice based user inputs related to the user's daily ‘diary’for tracking and recording the user's parameters. For example, insteadof presenting GUI screens of FIGS. 8 through 13 to the user to track andrecord the user's parameters related to appetite, exercise, hunger,stimulation sessions, weight and well-being, the HMA in communicationwith the IPA system enables voice based prompts to be delivered to theuser for each of the user parameter and allows the user to track andrecord these parameters via voice based inputs, commands orinstructions. For example, in some embodiments, the HMA in communicationwith the IPA system enables a voice recognition verbal/auditory numericor intensity scale, which may be, for example, a huger scale, to allowthe user to record hunger level (appetite, exercise or any other daily‘diary’ based parameter, for example) and hunger event/episode(including date and time of the hunger event) and use that as a triggerto initiate or titrate therapy. In embodiments, the verbal/auditoryhunger scale may be a 1 to 10 analog numeric hunger scale or an analogintensity hunger scale where descriptors such as “not hungry”, “somewhathungry” and “extremely hungry” are spoken to the user to choose from inorder to indicate/input the user's current state of hunger. Inembodiments, the verbal/auditory scale is activated by a verbal input orcommand (to the IPA system) such as, but not limited to, “I'm hungry”.

-   Following is an exemplary, non-limiting, simulated interaction that    may occur using the IPA system: Patient: I'm hungry-   IPA system: how hungry are you on a scale of 1 to 10-   Patient: Not very . . . I'd say 5/10-   IPA system: Thanks, your scheduled meal is only in 45 minutes so    let's see if you can hang on until then [hunger event is recorded]-   But if the patient responds Very, I'm at a 6/10-   IPA system: hang in there, I'm going to give you a mild rescue    session [A 15 minutes stimulation therapy at 10 mA is automatically    initiated], following which:-   IPA system: I think that will help—your next meal is only 60 minutes    away, just let me know if you need more help, I'm by your side.-   Instead, if the patient says: I'm very hungry . . . 8/10-   IPA system: hang in there, I'm going to give you a full rescue    session [A 15 minutes stimulation therapy at 20 mA is automatically    initiated]-   The aforementioned voice based interaction illustrates how the HMA    in communication with the IPA system enables voice based input of a    daily ‘diary’ parameter by the user and based on at least the level    (on a verbal/auditory scale) and time of input of the parameter how    the user's stimulation, including rescue sessions, may be triggered    and/or titrated.

Following is another exemplary, non-limiting, simulated interaction thatmay occur using the IPA system:

-   Patient: my hunger today was pretty intense around mid morning-   IPA system: sorry to hear that. I notice that you didn't use your    stimulation rescue button during that time. Why don't you activate    your rescue button at 10:00 am tomorrow? By the way you are doing    really well with your weight loss and have lost just over 8 pounds    so far, better than the average for other users. Nice job!!

In various embodiments, the HMA in communication with the IPA systemalso enables voice based dietary coaching depending upon the user'sverbal input of his daily ‘diary’ parameter.

FIG. 48C is a block diagram illustration of the HMA, of the presentspecification, in communication with the IPA system as well as a BigData database server, in accordance with an exemplary embodiment. Inthis embodiment, the HMA as well as the IPA software application areinstalled or implemented, as client side software components, on thecompanion device 4805 which is in data communication with at least oneEDP device 4810 of the present specification. The client side HMA andIPA software components, on the companion device 4805, are in datacommunication with each other. The IPA software component, on thecompanion device 4805, may or may not be in direct communication withthe at least one EDP device 4810. The companion device 4805 is also incommunication, via network 4825, with the health management server 4815that implements the server side software component of the HMA, the IPAserver 4835 that implements the server side software component of theIPA software application and optionally a remote patient care facilityand/or patient care personnel. The network 4825 is a cellular, Internet,TCP/IP, Ethernet, Bluetooth, wired, or wireless network. Also, thehealth management server 4815 and the IPA server 4835 are capable ofbeing in data communication with each other through network 4825. Inaccordance with an aspect of the present specification, the server sidesoftware component of the HMA, apart from being in communication withthe IPA system, is also in communication with a Big Data database server4840 through the network 4825. The Big Data database server 4840, vianetwork 4825, is in communication with the EDP device 4810 and thecompanion device 4805 to store a plurality of health related data of theuser. In various embodiments, the Big Data database server 4840, vianetwork 4825, is in communication with a plurality of networks or groupsof a plurality of users each using an EDP device (such as device 4810)and a corresponding companion device (such as device 4805). Thus, invarious embodiments, the Big Data database server 4840 is able to accessand store a plurality of aggregated health related data of a pluralityof networks or groups of users (hereinafter referred to as users'“health related data”). In various embodiments, the health related dataalso includes attributes data such as, but not limited to, date ofbirth, work address, home address, social security number, gender,height, occupation, income, present and past ailments and medications,history of ailments in the family. The Big Data database server 4840,via network 4825, is also in communication with a plurality of genericdata sources or databases such as, but not limited to, those associatedwith news, weather and climate forecasts, demographics, genome,geographical maps, electronic health records, GPS, merchant or shoppingtransaction records such as supermarkets or shop checkouts data, publicholidays, festivals, and other data. Thus, in various embodiments, theBig Data database server 4840 is able to store a plurality of data(hereinafter referred to as “general data”) by accessing a plurality ofgeneric data sources.

In one embodiment the server side software component of the HMA alsoimplements a Big Data analytics engine that mines the Big Data databaseserver 4840 to analyze a plurality of users' health related data(including attributes data) as well as general data, generate aplurality of patterns and correlations from the users' health relateddata and general data, predict what effects such patterns andcorrelations may have on a specific user, and eventually generates andimplements a plurality of predictive stimulation therapy regimens oroutcomes corresponding to the predicted effects. In various embodiments,the Big Data analytics engine is an artificial intelligence programimplementing one or more of a case based reasoning (constituting aprocess of solving new problems based on the solutions of similar pastproblems), fuzzy logic (constituting a process of solving problems basedon degrees of truth rather than the usual true or false Boolean logic)and/or rule based reasoning (constituting a process of solving problemsbased on a plurality of pre-defined rules or criterion).

In some embodiments, the Big Data analytics engine analyzes a pluralityof users' historical (of the past predefined period of time such asweeks, months or years) as well as current (of a given day) healthrelated data (such as, but not limited to, historical and current daily‘diary’ entries, caloric intake, and exercise trend) to predict onset ofa hunger event and proactively trigger or recommend a stimulationsession (for example, a rescue session) prior to the predicted orforecasted hunger event.

In some embodiments, the Big Data analytics engine mines the generaldata and identifies a plurality of adverse factors that are likely tocontribute to an EDP user's failure to achieve his goal, such as aweight loss goal. For example, historical shopping data may suggestincreased buying of less healthy or high calorie eateries such as savoryor gourmet foods and carbonated soft drinks at and around festive seasonsuch as Christmas or around holidays such as Thanksgiving. If the EDPuser has a high positive energy balance and the festive season isapproaching, the HMA, via the IPA system, will automatically generate analert prompting the user to be careful and not indulge in unhealthyeating during a certain high risk period of time such as a few daysbefore and after Christmas, for example. Similar alerts areautomatically generated when the user's birthday approaches.

In some embodiments, the Big Data analytics engine may associate generaldata with the user's health and attributes data. For example, if theuser's GPS coordinates are known additional general data can beassociated with the user such as, but not limited to, weather, timezone, venue and venue categories (for example, at home, work, a bar, arestaurant, a concert hall). If the user's GPS coordinates indicatepresence of the user in a bar or a restaurant, the HMA may automaticallyalert the user with regards to potential over indulgence. In anotherembodiment, if historical trends suggest a correlation of the user'sspike in positive energy balance following visits to the bar or therestaurant, then the HMA may automatically schedule a preventivestimulation session on the user's next visit to the bar or restaurant,in order to suppress appetite. In another example, the Big Dataanalytics engine may access the user's OpenTable (an onlinerestaurant-reservation service) reservation or the user's Calendarappointment for a visit to a bar or a restaurant. Accordingly, the HMAmay automatically alert the user with regards to potential overindulgence prior to the user's visit to the bar or restaurant and eventtrigger or recommend a rescue session prior to the user's visit to thebar or restaurant.

In another example, considering people with the same gene as that of theuser and the same level of sunlight exposure available as in thelocation of the user, the user may have a high likelihood of deficiencyin Vitamin D. This correlation may be further accentuated if the user'sexercise regimen is largely limited to indoor workouts. Accordingly, theHMA may automatically recommend the user for periodic tests for VitaminD and encourage the user to include ample outdoor exercise or workouts.

In still other embodiments, the Big Data analytics engine may identify astatistically significant trend, where the user feels more tired on daysfollowing intense exercise. In the same example, the system may findthat the user's sleep is more fragmented on nights following intenseexercise. In one embodiment, if the correlation between intenseexercise, fragmented sleep and depleted energy on the following day isstrong enough, and no other significant correlations are made despiteadequate data sources and types, intense exercise or workout is flaggedas a potential contributing factor to negative well-being. In anotherembodiment, the user-specific trend can be compared to aggregate data,in order to reinforce the validity of the user-specific correlation. Forexample, the Big Data analytics engine may go on to find that asubstantial portion of the general population also experiencesfragmented sleep on nights following intense workouts. Accordingly, theHMA may, via the IPA system, alert the user when the user's exerciseintensity on a particular day is high and suggest a moderated exercisingregimen.

Electro-Dermal Patch Device Placement

In various embodiments, the electro-dermal patch device (such as theelectro-dermal patch device 110 of FIG. 1A through 1C) of the presentspecification is placed at or near an ‘area of interest’ on the user'sbody to provide stimulation therapies for a plurality of conditions ortreatments.

In various embodiments, the ‘area of interest’ comprises a dermatome. Asunderstood by persons of ordinary skill in the art, a dermatome is anarea of skin supplied by sensory neurons that arise from a spinal nerveganglion. There are 8 cervical nerves (C1 being an exception with nodermatome), 12 thoracic nerves, 5 lumbar nerves and 5 sacral nerves.Each of these nerves relays sensation from a particular region of skinto the brain.

In some embodiments, the ‘area of interest’ comprises a thoracicdermatome, such as the user's front or lateral T2 to T12 dermatomes. Inother embodiments, the ‘area of interest’ comprises a dermatome, such asthe user's front (anterior) and/or back (posterior) C5-T1 dermatomes inthe hand and arm along with the front (anterior) C5-T1 dermatomes on theupper chest region (hereinafter together referred to as ‘handdermatomes’). In various embodiments, the ‘area of interest’ expresslyexcludes the back (posterior) C5-T1 dermatomes of the upper chest regionsince the back portions are inaccessible to the user and therefore wouldneed a medical practitioner to apply the devices of the presentspecification. In still other embodiments, the ‘area of interest’comprises epidermis regions for stimulating a median nerve in the hand,and more specifically, in the wrist region.

In some embodiments, however, the ‘area of interest’ includes the back(posterior) T2-T12 and/or C5-T1 dermatomes. In such embodiments, the EDPdevice of the present specification is configured to be positioned onthe back dermatomes by the user with ease and with minimal or no helpfrom a third party such as a medical practitioner. Accordingly, in someembodiments, the EDP device is incorporated into a tight undershirtwhich when worn by the user simply positions the incorporated EDP deviceat the desired back dermatome. In some embodiments, the user is enabledto position the EDP device on the desired back dermatome using anelastic band, strap or belt encircling his trunk, wherein the elasticband, strap or belt incorporates the EDP device of the presentspecification.

In some embodiments, the ‘area of interest’ comprises at least one ofthe patient's T2 front, lateral and/or back thoracic dermatome, T3front, lateral and/or back thoracic dermatome, T4 front, lateral and/orback thoracic dermatome, T5 front, lateral and/or back thoracicdermatome, T6 front, lateral and/or back thoracic dermatome, T7 front,lateral and/or back thoracic dermatome, T8 front, lateral and/or backthoracic dermatome, T9 front, lateral and/or back thoracic dermatome, orT10 front, lateral and/or back thoracic dermatome. In some embodiments,the ‘area of interest’ comprises at least one of the patient's T2frontal and lateral thoracic dermatome, T3 frontal and lateral thoracicdermatome, T4 frontal and lateral thoracic dermatome, T5 frontal andlateral thoracic dermatome, T6 frontal and lateral thoracic dermatome,T7 frontal and lateral thoracic dermatome, T8 frontal and lateralthoracic dermatome, T9 frontal and lateral thoracic dermatome, and T10frontal and lateral thoracic dermatome and does not include any one ofthe patient's T2 posterior thoracic dermatome, T3 posterior thoracicdermatome, T4 posterior thoracic dermatome, T5 posterior thoracicdermatome, T6 posterior thoracic dermatome, T7 posterior thoracicdermatome, T8 posterior thoracic dermatome, T9 posterior thoracicdermatome, and T10 posterior thoracic dermatome.

In some embodiments, the ‘area of interest’ comprises at least one ofthe patient's C8 anterior or posterior dermatome located on thepatient's hand, wrist, elbow, and fingers, C8 anterior or posteriordermatome located on the patient's arm, C8 dermatome located on thepatient's upper trunk, T1 anterior or posterior dermatome located on thepatient's arm, T1 anterior or posterior dermatome located on thepatient's wrist, elbow, and hand, and T1 anterior or posterior dermatomelocated on the patient's upper trunk.

In some embodiments, the ‘area of interest’ comprises at least one ofthe patient's C5, C6, C7, C8, T1, T2, T3, T4, T5, T6, T7, T8, T9, T10,T11, and T12 frontal, lateral and/or back dermatomes.

In some embodiments, the ‘area of interest’ comprises at least one ofthe patient's C5, C6, C7, C8, T1, T2, T3, T4, T5, T6, T7, T8, T9, T10,T11, and T12 frontal and lateral dermatomes and does not include anyportion of the patient's C5, C6, C7, C8, T1, T2, T3, T4, T5, T6, T7, T8,T9, T10, T11, and T12 posterior dermatomes.

In alternate yet less preferred embodiments, the ‘area of interest’comprises one or more meridians.

FIG. 17A is an illustration depicting the distribution 1700 of the frontand lateral, or frontal, T2-T12 dermatomes across a thorax and abdomen,that is trunk, of a human body. The frontal dermatome is defined as thefront and lateral thoracic dermatome which expressly do not include theback or spinal roots of said patient. In various embodiments, theelectro-dermal patch devices of the present specification are positionedon the surface of the epidermis on the front portion 1702 or lateralportion 1704 of the T2-T12 dermatomes. The electrode(s) positioned inthe pads or skin patches of the electro-dermal patch device then provideelectrical stimulation to the epidermis of the targeted dermatome(s).The T2 to T12 dermatomes are anatomically identifiable as follows:

-   T2—At the apex of the axilla.-   T3—Intersection of the midclavicular line and the third intercostal    space.-   T4—Intersection of the midclavicular line and the fourth intercostal    space, located at the level of the nipples.-   T5—Intersection of the midclavicular line and the fifth intercostal    space, horizontally located midway between the level of the nipples    and the level of the xiphoid process.-   T6—Intersection of the midclavicular line and the horizontal level    of the xiphoid process.-   T7—Intersection of the midclavicular line and the horizontal level    at one quarter the distance between the level of the xiphoid process    and the level of the umbilicus.-   T8—Intersection of the midclavicular line and the horizontal level    at one half the distance between the level of the xiphoid process    and the level of the umbilicus.-   T9—Intersection of the midclavicular line and the horizontal level    at three quarters of the distance between the level of the xiphoid    process and the level of the umbilicus.-   T10—Intersection of the midclavicular line, at the horizontal level    of the umbilicus.-   T11—Intersection of the midclavicular line, at the horizontal level    midway between the level of the umbilicus and the inguinal ligament.-   T12—Intersection of the midclavicular line and the midpoint of the    inguinal ligament.

FIG. 17B is an illustration depicting the distribution 1701 of the frontand back, C5-T1 dermatomes across the hand 1705, arm 1710 and upperchest 1715 regions of a human body. In various embodiments, theelectro-dermal patch devices of the present specification are positionedon the surface of the epidermis on the front portion 1720 and/or backportion 1725 of the C5-T1 dermatomes on the hand 1705 and arm 1710 alongwith the front (anterior) C5-T1 dermatomes on the upper chest 1715. FIG.17C is an illustration depicting the distribution of the C5-T1dermatomes across the hand 1705 and lower arm 1711 regions. In variousembodiments, the electro-dermal patch devices of the presentspecification are positioned on the surface of the epidermis on thefront (palm) and/or back side of the hand 1705 targeting the C6-C8dermatomes or on the front and/or back side of the lower arm 1711 (suchas at a wrist region, for example) targeting the C5 and T1 dermatomes.The electrode(s) positioned in the pads or skin patches of the devicethen provide electrical stimulation to the epidermis of the targeteddermatome(s).

The C5-T1 dermatomes are anatomically identifiable as follows:

-   C5—On the lateral (radial) side of the antecubital fossa, just    proximally to the elbow.-   C6—On the dorsal surface of the proximal phalanx of the thumb.-   C7—On the dorsal surface of the proximal phalanx of the middle    finger.-   C8—On the dorsal surface of the proximal phalanx of the little    finger.-   T1—On the medial (ulnar) side of the antecubital fossa, just    proximally to the medial epicondyle of the humerus.

As shown in FIG. 17E, in some embodiments, the electro-dermal patchdevices of the present specification are positioned on the surface ofthe epidermis on the front 1740 and/or back side 1745 of the wristregion 1750 targeting the median nerve. The electrode(s) positioned inthe pads or skin patches of the device then provide electricalstimulation to the epidermis of the targeted median nerve. In the hand,the median nerve supplies motor innervation to the 1st and 2nd lumbricalmuscles. It also supplies the muscles of the thenar eminence by arecurrent thenar branch. The median nerve innervates the skin of thepalmar side of the index, the thumb and middle finger, half the ringfinger, and the nail bed. The lateral part of the palm is supplied bythe palmar cutaneous branch of the median nerve, which leaves the nerveproximal to the wrist creases. Thus, in some embodiments, the epidermisregion 1752 on the front side 1740 and/or the epidermis region 1754 onthe back side 1745 of the wrist region 1750 are electrically stimulatedto target the median nerve to cause satiety, weight loss and/ormetabolic improvement.

It should be appreciated that in some embodiments the hand dermatomes,such as the C5-T1 dermatomes, as well as the epidermis regions relatedto stimulation of the median nerve in the wrist region are stimulatedusing conductive metal electrodes (such as, but not limited to, of Gold)without any adhesive skin patches. In such embodiments, the conductivemetal electrodes are positioned on an appropriate epidermis (with userapplied conductive gel, in some embodiments) to deliver electricalstimulation pulses without any skin patch. In an embodiment, theconductive metal electrodes stimulate dermatomes C8 and T1 at thelocation of the Median nerve under the wrist (ventral side). In oneembodiment, the electrodes are on opposing sides of the nerve.

FIG. 17D is a flow chart listing the steps involved in one method ofidentifying a proper placement location for an electro-dermal patch on afront thoracic surface of a patient, in accordance with one embodimentof the present specification. At step 1732, the patient, a physician, oranyone placing the EDP device on the patient, finds a midclavicular lineof the patient. The person applying the device then progresses downwardfrom the midclavicular line to a bottom rib of a thoracic cage of thepatient at step 1734. From the bottom rib, at step 1736, the personapplying the device moves downward by 2 cm to identify a placement spot.At step 1738, the person applying the device places a top center portionof the electro-dermal patch at the placement spot.

Referring back to FIG. 1A, in various embodiments, at least one thoracicdermatome, from T2 to T12 and/or ‘arm dermatome’ or ‘hand dermatome’C5-T1, is stimulated by the electro-dermal patch device 110 to provideelectrical stimulation therapy, from the external surface of thepatient's epidermal layer through 10 mm or 20 mm of the dermis, whereinthe one or more electrodes 118 are configured to be positioned in skinpatches or pads as described with reference to FIGS. 2A through 2C,FIGS. 3A, 3B, and 4A through 4C.

The prior art has focused on one of three different approaches: 1)stimulating the back, near the spinal root, 2) providing percutaneouselectrical stimulation, which requires an electrode to be implanted, or3) stimulating using conventional acupuncture meridians. However, theelectro-dermal patch device 110 of the present specification provideselectrical stimulation, from the external surface of the patient'sepidermal layer through 10 mm or 20 mm of the dermis, and targets front,lateral or back thoracic dermatomes and/or front or back ‘handdermatomes’ (excluding the back C5-T1 dermatomes in the upper backregion), in accordance with various embodiments, having nerves that arecloser to the skin surface. The electro-dermal patch device 110 of thepresent specification generates an electrical field, defined as voltageover distance, which penetrates to a shallower depth compared tostimulation encountered in the prior art. This allows the electro-dermalpatch device 110 to have relatively smaller electrodes 118, lowers thecurrent density and therefore the device requires less power than priorart devices to affect target tissues. The electrical field generated bythe EDP device 110 is a function of at least the electrode geometry,electrode-tissue interface impedance, and the stimulating currentamplitude. Providing an integrated device design and targeting thefront, lateral or back thoracic dermatomes and/or C5-T1 dermatomesallows the patient to apply the electro-dermal patch device andstimulation independently. Prior art devices, particularly thosestimulating the back (posterior side), require a medical professionalfor application.

In some embodiments, the electro-dermal patch device 110 stimulatesareas in the T6 and/or T7 dermatome. In some embodiments, theelectro-dermal patch device 110 stimulates areas in at least one of T6through T10 dermatomes. In some embodiments, the electro-dermal patchdevice 110 stimulates areas in the C8 and/or T1 dermatome on the hand ofa patient. In still other embodiments, the electro-dermal patch device110 stimulates areas in the T6, T7, C8 and/or T1 dermatomes.

In one embodiment, as shown in FIG. 18A, the electro-dermal patch device1800 stimulates the T6 dermatome, including meridians. In anotherembodiment, as shown in FIG. 18B, the electro-dermal patch device 1810stimulates the T7 dermatome. In yet another embodiment, as shown in FIG.18C, the electro-dermal patch device 1820 stimulates both the T6 and T7dermatomes. In some embodiments, referring to FIG. 18A, anelectro-dermal patch device 1800 delivers, through one or moreelectrodes disposed in a pad or skin patch, electrical stimulation 1802above a rib (T6) and electrical stimulation 1804 below the rib (T6) tostimulate an intercostal nerve 1805 and the T6 dermatome. In oneembodiment, the EDP device 1800 is positioned 2 cm below the margin oredge of the rib cage (on at least one of either side of the abdomen) tostimulate the T6 dermatome. In other embodiments, referring to FIG. 18B,an electro-dermal patch device 1810 delivers, through one or moreelectrodes disposed in a pad or skin patch, electrical stimulation 1812above a rib (T7) and electrical stimulation 1814 below the rib (T7) tostimulate an intercostal nerve 1815 and the T7 dermatome. In oneembodiment, the EDP device 1810 is positioned 2-6 cm (preferably 3.5 to4.5 cm) below the margin or edge of the rib cage (on at least one ofeither side of the abdomen) to stimulate the T7 dermatome. In yet otherembodiments, referring to FIG. 18C, an electro-dermal patch device 1820delivers, through one or more electrodes disposed in a pad or skinpatch, electrical stimulation 1822 below a rib (T6) and above a rib (T7)and electrical stimulation 1824 below a rib (T7) to stimulateintercostal nerves 1825, 1835 and the T6 and T7 dermatomes. In oneembodiment, the EDP device 1820 is positioned 2.5 cm to 3.5 cm below themargin or edge of the rib cage (on at least one of either side of theabdomen) to stimulate both the T6 and T7 dermatomes.

In one embodiment, the electro-dermal patch device 1800 is positioned ona very specific portion of the patient's T6 dermatome. Specifically, theEDP device 1800 is positioned on the left upper quadrant along themid-clavicular line, 2 cm below the ribcage at a 90 degree angle towardsthe abdominal wall at a depth of approximately 0.5-1 cm. In other words,the EDP device 1800 is positioned at the intersection of two lines drawnon a standing patient: a first line vertically down from a mid-clavicleand a second line horizontally across from the xyphoid process. Thefirst and second lines would form an angle of 90 degrees on the rightside and left side of the anterior trunk of the patient.

In accordance with an aspect of the present specification, the T6dermatome is stimulated to treat conditions such as obesity,over-weight, eating disorders, metabolic syndrome and/or for appetitesuppression. In accordance with another aspect of the presentspecification, the T7 dermatome is stimulated to treat T2DM (Type 2Diabetes Mellitus). In accordance with yet another aspect of the presentspecification, any one of T6 through T10 dermatome is stimulated totreat T2DM. In accordance with yet another aspect of the presentspecification, up to two dermatomes, such as T6 and T7, aresimultaneously or alternatingly stimulated to treat multiple conditions(e.g., appetite suppression and T2DM). In accordance with still anotheraspect of the present specification, any two dermatomes, from T6 throughT10 dermatomes, are simultaneously or alternatingly stimulated. Inaccordance with another aspect of the present specification, the C8 orT1 dermatome is stimulated to treat conditions such as obesity,over-weight, eating disorders, metabolic syndrome and/or for appetitesuppression. In accordance with yet another aspect of the presentspecification, up to two dermatomes, such as C8 and T1, aresimultaneously or alternatingly stimulated. In still furtherembodiments, T6, C8 and/or T1 dermatome is stimulated to treatconditions such as obesity, over-weight, eating disorders, metabolicsyndrome and/or for appetite suppression, while the T7 dermatome isstimulated to treat T2DM (Type 2 Diabetes Mellitus). In still additionalembodiments, multiple dermatomes are simultaneously stimulated, forexample any one or any combination of T6, T7, C8 and/or T1 dermatomesare stimulated simultaneously.

In some embodiments, the electro-dermal patch device 110 stimulatesareas in the C8 and/or T1 dermatome on the hand of a patient. In stillother embodiments, the electro-dermal device 110 stimulates the mediannerve at the wrist region. In one embodiment, as shown in FIG. 19A, theelectro-dermal patch device 1900, through one or more electrodesdisposed in a pad or skin patch, stimulates the C8 dermatome on thefront (palm) or ventral side 1905 of the hand 1910. In anotherembodiment, as shown in FIG. 19B, the electro-dermal patch device 1900,through one or more electrodes disposed in a pad or skin patch,stimulates the C8 dermatome on the back or dorsal side 1906 of the hand1910. In yet another embodiment, as shown in FIG. 19C, theelectro-dermal patch device 1900, through one or more electrodesdisposed in a pad or skin patch, stimulates both the C8 and T1dermatomes by being placed on the front or ventral side of the lower armor wrist region 1915. In some embodiments, as shown in FIG. 19D, theelectro-dermal patch device 1900, through one or more electrodesdisposed in a pad or skin patch, stimulates the epidermis region 1920 onthe front side 1930 and/or the epidermis region 1925 on the back side1935 of the wrist region 1940 to target the median nerve.

It should be appreciated that, in various embodiments, theelectro-dermal patch device 1900 is placed in-line with the patient'sfingers, such that a longitudinal axis 1901 of the electro-dermal patchdevice 1900 is approximately in the direction of the fingers. However,in various alternate embodiments the electro-dermal patch device may notbe placed in-line with the patient's fingers. In various embodiments,the electro-dermal patch device 1900 is placed on a non-dominant hand ofthe patient. In some embodiments, the electro-dermal patch device 1900is preferably placed on the back or dorsal side of the hand (as shown inFIG. 19B) as the patient's palm (ventral side) comes into contact withmany surfaces in daily routine that may cause damage to theelectro-dermal patch device 1900.

In accordance with an aspect, the electro-dermal patch device 1900 issufficiently flexible so that it conforms to the contour of the user'shand 1910 and does not interfere in free movement of the hand 1910.Referring back to FIG. 1A, to enable sufficient flexibility of theelectro-dermal patch device 110 (that is, electro-dermal patch device1800 configured as a skin patch as shown in FIGS. 19A through 19C) theunderlying electronics such as the microcontroller 112, transceiver 114,the pulse generator 116 and the power management module 120 includingthe receptor slots 130 are mounted on flexible plastic substrates, suchas polyimide, PEEK (Polyether Ether Ketone) or transparent conductivepolyester film—to form flex circuits. Alternatively, the underlyingelectronics are substantially miniature so that their rigid substrate,in some embodiments, do not need to flex over their small area. In someembodiments, the power management module 120 including the receptorslots 130, the actuators 122 and the indicators 124, 126 are physicallyseparated or at a distance from the electronic circuitry such as themicrocontroller 112, transceiver 114, and the pulse generator 116 toenable increased flexibility. In various embodiments, the housing 111 ofthe electro-dermal patch device 110 is of a flexible material such assilicone, rubber or any other flexible polymer known to persons ofordinary skill in the art.

In some embodiments, the electro-dermal patch device, through one ormore electrodes disposed in a pad or skin patch, is configured tostimulate the C8 dermatome on the front (palm side) or ventral side aswell as the back or dorsal side of the user's hand. In one embodiment,as shown in FIG. 20A, the electro-dermal patch device 2000 comprises afirst patch portion 2015, a second patch portion 2020 and a third patchportion or bridge 2025 connecting the first and second patch portions2015, 2020. In some embodiments, the first and second patch portions2015, 2020 are substantially semi-circular shaped that are connected bya substantially rectangular bridge 2025 such that the electro-dermalpatch device 2000 forms an approximate ‘hourglass’ shape. In anotherembodiment, as shown in FIG. 20B, the first and second patch portions2015′, 2020′ are substantially rectangular that are connected by asubstantially rectangular bridge 2025′ such that the electro-dermalpatch device 2000′ forms an approximate ‘H’ shape. In variousembodiments, the bridge 2025, 2025′ is narrow (that is, the width issubstantially less than the length of the bridge) to increaseflexibility of this segment of the electro-dermal patch device 2000,2000′. It should be appreciated that the ‘hourglass’ and ‘H’ shapedconfigurations of FIGS. 20A, 20B are non-limiting examples of thevarious shapes that the electro-dermal patch device may have in variousembodiments.

In some embodiments, all three patch portions 2015, 2020 and 2025 areadhesive. However, in alternate embodiments only the first and secondpatch portions 2015, 2020 are adhesive while the bridge portion 2025 isnon-adhesive to improve comfort, wearability tolerance and overallflexibility of the patches 2000, 2000′. The non-adhesive bridge portion2025 may be configured into a thinner portion relative to the adhesivefirst and second adhesive patch portions 2015, 2020.

During use, the electro-dermal patch devices 2000, 2000′ respectivelywrap around the edge 2011 of the hand 2010 such that the first patchportion 2015 adheres to or lies on the front (palm) or ventral side2005, the second patch portion 2020 adheres to or lies on the back ordorsal side 2006 while the bridge 2025 wraps around the edge 2011 of thehand 2010. In accordance with an aspect of the present specification, afirst electrode is disposed in the first patch portion 2015 to stimulatethe C8 dermatome on the ventral side 2005 and a second electrode isdisposed in the second patch portion 2020 to stimulate the C8 dermatomeon the dorsal side 2006 of the hand 2010.

In some embodiments, the electro-dermal patch devices 2000, 2000′ areconfigured such that the underlying electronic circuitry including thepower management module are disposed on one of the first or second patchportions 2015, 2020. Thus, referring to FIGS. 1A, 20A, 20B theelectro-dermal patch device 110 is configured or disposed as patches2000, 2000′ of FIGS. 20A, 20B such that the microcontroller 112,transceiver 114, pulse generator 116, the power management module 120including the receptor slots 130, actuators 122 and the indicators 124,126 are located on either the first or the second patch portions 2015,2020. In one embodiment, the microcontroller 112, transceiver 114, pulsegenerator 116, the power management module 120 including the receptorslots 130, actuators 122 and the indicators 124, 126 are located on thesecond patch portion 2020 i.e., the patch portion that adheres to theback or dorsal side 2006 of the hand 2010 to avoid damage to theelectronic components from daily use.

In other embodiments, the electro-dermal patch devices 2000, 2000′ areconfigured such that the underlying circuitry and the power managementmodule are distributed between the first and second patch portions 2015,2020. Thus, referring to FIGS. 1A, 20A, 20B the electro-dermal patchdevice 110 is configured or disposed as patches 2000, 2000′ of FIGS.20A, 20B such that the microcontroller 112, transceiver 114, pulsegenerator 116 the power management module 120 including the receptorslots 130, actuators 122 and the indicators 124, 126 are distributed andtherefore physically separated between the first and second patchportions 2015, 2020 to improve flexibility of the electro-dermal patchdevices 2000, 2000′. In one embodiment, the microcontroller 112,transceiver 114, pulse generator 116, actuators 122 and the indicators124, 126 are located on, say, the first patch portion 2015 (that adheresto the ventral or palm side 2005 of the hand 2010) whereas the powermanagement module 120 including the receptor slots 130 is located on thesecond patch portion 2020 (that adheres to the dorsal or back side 2006of the hand 2010). In another embodiment, the microcontroller 112,transceiver 114, pulse generator 116, actuators 122 and the indicators124, 126 are located on, say, the second patch portion 2020 (thatadheres to the dorsal or back side 2006 of the hand 2010) whereas thepower management module 120 including the receptor slots 130 is locatedon the first patch portion 2015 (that adheres to the ventral or palmside 2005 of the hand 2010).

Continuing to refer to FIGS. 1A, 20A, 20B, in one embodiment, the firstand second electrodes 118 as well as the sensors 135 are disposed on thefirst patch portion 2015 i.e., the patch portion that adheres to thefront (palm) or ventral side 2005 of the hand 2010. In anotherembodiment, the first and second electrodes 118 are disposed on thefirst patch portion 2015 while the sensors 135 are located on the secondpatch portion 2020. In yet another embodiment, the first and secondelectrodes 118 are disposed on the second patch portion 2020 while thesensors 135 are located on the first patch portion 2020. In stillfurther embodiments, the first and second electrodes 118 arerespectively disposed on the first and second patch portions 2015, 2020while the sensors 135 are located on either the first or the secondpatch portion 2015, 2020. It should be noted that while in variousembodiments, the electro-dermal patch devices of FIGS. 19A, 19B, 19C,19D, 20A and 20B have been illustrated as being placed at locations onthe hand of the user, in various alternate embodiments theseelectro-dermal patch devices may be placed at other points to stimulatethe C5-C8 and/or T1 dermatomes on the user's arms or upper chest regionsas well. It should further be appreciated that in some embodiments thehand dermatomes, such as the C5-T1 dermatomes, as well as the epidermisregions related to stimulation of the median nerve in the wrist regionare stimulated using conductive metal electrodes (such as, but notlimited to, of Gold) without any adhesive skin patches. In other words,the electrodes are not disposed in an adhesive skin patch. In suchembodiments, the conductive metal electrodes are positioned on anappropriate epidermis (with user applied conductive gel, in someembodiments) to deliver electrical stimulation pulses without any skinpatch. In an embodiment, the conductive metal electrodes stimulatedermatomes C8 and T1 at the location of the Median nerve under the wrist(ventral side). In one embodiment, the electrodes are positioned onopposing sides of the Median nerve.

In accordance with another aspect, the EDP device 110, 140 or 160 ofFIGS. 1A through 1C is configured as a wearable gear to stimulate areasin the C8 and/or T1 dermatome on the hand of the patient. Accordingly,in some embodiments, the EDP device of the present specification isconfigured as a wristband or wristwatch, as shown in FIGS. 21A and 21B,respectively. It should be noted that as a wristband or wristwatch, theEDP device may not include an adhesive and the contact integrity withthe user's skin may be less compared to stick-on patch configurations ofthe EDP device. Referring now to FIG. 21A, the wristband 2105 comprisesa flexible band or strap 2110 that is worn to wrap around the wrist ofthe patient. The flexible band 2110 has an inner surface (not visible)that, when worn, interfaces with the skin of the patient and an outersurface 2115. The band 2110 is strapped around the wrist and held inplace using conventional fastening means such as, but not limited to,Velcro, clasps, or buckle fastening. In accordance with an embodiment,the EDP device 2100, which may be similar to the EDP device 110, 140 or160 of FIGS. 1A through 1C, is incorporated within the flexible band2110 such that the inner surface of the flexible band 2110 exposes theone or more electrodes 2118 to touch the external surface of thepatient's epidermal layer when the wristband 2105 is worn around thewrist. To enable visibility and for illustration purposes, the EDPdevice 2100 and the one or more electrodes 2118 have been shown exposed,in FIG. 21A, through the outer surface 2115. It should however beappreciated that the EDP device 2100, in various embodiments, liesembedded within and between the inner and outer surfaces of the flexibleband 2110 while allowing only the one or more electrodes 2118 to beexposed through the inner surface of the band to allow contact with thepatient's skin. In various embodiments, the EDP device 2100 is locatedwithin the band 2110 such that when worn, the one or more electrodes2118 stimulate both the C8 and T1 dermatomes by touching or contactingthe front or ventral side of the wrist region 2120. In a preferredembodiment, the EDP device 2100 is located within the band 2110 suchthat when worn, the one or more electrodes 2118 touch or contact theulnar region (where dermatomes C8 and T1 meet) of the front or ventralside of the wrist region 2120.

In various alternate embodiments, the EDP device 2100 is configured inthe form of an armband (instead of the wristband 2105). This embodimentis similar to the wristband 2105 in terms of the overall structure anddesign, however the flexible band 2110 is sized to be worn anywhere onthe arm of the patient such that the one or more electrodes 2118stimulate the C8 dermatome of the patient.

In another alternate embodiment, the EDP device is configured in theform of a wristwatch 2106 as shown in FIG. 21B. Referring to FIG. 21B,the wristwatch 2106 comprises a flexible band 2110 that is worn to wraparound the wrist of the patient. The flexible band 2110 has an innersurface 2114 that, when worn, interfaces with the skin of the patientand an outer surface 2115. The band 2110 is strapped around the wristand held in place using conventional fastening means such as, but notlimited to, Velcro, clasps, or buckle fastening. In accordance with anembodiment, the EDP device 2100, which may be similar to the EDP device110, 140 or 160 of FIGS. 1A through 1C, is incorporated within theflexible band 2110 such that the inner surface 2114 of the flexible band2110 exposes the one or more electrodes 2118 that touch the externalsurface of the patient's epidermal layer when the wristwatch 2106 isworn around the wrist. In various embodiments, the EDP device 2100 islocated within the band 2110 such that when worn, the one or moreelectrodes 2118 stimulate both the C8 and T1 dermatomes by touching orcontacting the front or ventral side of the wrist region. A dial 2125,which, in some embodiments, comprises a GUI (Graphical User Interface)attached to the band 2110, is located on the dorsal side of the wristwhen the wristwatch 2106 is worn by the patient. In a preferredembodiment, the EDP device 2100 is located within the band 2110 suchthat when worn, the one or more electrodes 2118 touch or contact theulnar region (where dermatomes C8 and T1 meet) of the front or ventralside of the wrist region.

In some embodiments, the flexible band 2110 can be removed from the dial2125 and replaced with another similar flexible band. In still otherembodiments, the flexible band 2110 is detachable from the dial 2125 andworn at the wrist, arm or hand separate from the dial 2125. In suchembodiments, the EDP device 2100 located within the flexible band 2110is in wireless data communication with a smartphone (functioning as acompanion device) of the user. In still other embodiments, the EDPdevice 2100 configured to be worn on the wrist, arm or band, such as inFIG. 21A, is in data communication with the wristwatch 2106 of FIG. 21Bthat, alternatively, may not include the EDP device therein. In someembodiments, wrist mounted EDP device configurations, such as thosedescribed with reference to FIGS. 21A, 21B, operate at pulse amplitudesranging from 5 mA to 10 mA.

In various embodiments, the hand dermatomes, such as the C5-T1dermatomes, as well as the epidermis regions related to stimulation ofthe median nerve in the wrist region are stimulated using conductivemetal electrodes 2118 (such as, but not limited to, an embodiment wheregold is used as the conductive metal) without the use of adhesive skinpatches. In other words, the electrodes 2118 are not disposed in anadhesive skin patch. As discussed with reference to FIGS. 21A, 21B, theconductive metal electrodes 2118 are positioned on an appropriateepidermis (with user applied conductive gel, in some embodiments) todeliver electrical stimulation pulses without a skin patch. In anembodiment, the conductive metal electrodes 2118 stimulate dermatomes C8and T1 at the location of the Median nerve under the wrist (ventralside).

In other embodiments, the EDP device of the present specification isconfigured in the form of hand gloves that may be one (for wearing inone hand only) or a pair of gloves (for wearing in both hands). FIGS.22A, 22B, 22C and 22D respectively show first, second, third and fourthembodiments of hand gloves 2201, 2202, 2203, 2204 comprising at leastone EDP device 2200 a through 2200 j together referenced as EDP device2200. The gloves 2201, 2202, 2203, 2204 when worn, have an inner surface(not visible) that interface with the skin of the patient's hands, bothon the ventral as well as the dorsal sides, and an outer surface 2215.In accordance with an embodiment, the at least one EDP device 2200 (2200a through 2200 j), which may be similar to the EDP device 110, 140 or160 of FIGS. 1A through 1C, is incorporated within the gloves 2201,2202, 2203, 2204 such that the inner surface (of the gloves) exposes theone or more electrodes 2218 that touch the external surface of thepatient's epidermal layer when the gloves are worn. To enable visibilityand for illustration purposes, the EDP device 2200 and the one or morecorresponding electrodes 2218 have been shown exposed, in FIGS. 22Athrough 22D, through the outer surface 2215. It should however beappreciated that the EDP device 2200, in various embodiments, lies onthe inner surface of the gloves while allowing only the one or moreelectrodes 2218 to be exposed through the inner surface to allow contactwith the patient's skin.

FIGS. 22A through 22D illustrate a plurality of locations of one or moreEDP devices 2200 a through 2200 j for stimulating the C5-C8 and/or T1dermatomes of the patient's hands. While FIGS. 22A through 22D show theplurality of locations of one or more EDP devices 2200 (2200 a through2200 j) on the dorsal side of the patient's hands, it should beappreciated that one or more EDP devices 2200 can alternatively oradditionally be located on the ventral side of the patient's hands tostimulate the C8 and/or T1 dermatomes. Thus, in various embodiments oneor more EDP devices 2200 are located such that their correspondingelectrodes stimulate C5-C8 and/or T1 dermatomes on the dorsal and/orventral sides of the patient's one or both hands. To stimulate both theC8 and T1 dermatomes, in one embodiment, at least one EDP device 2200 islocated such that the corresponding electrodes 2218 contact the ulnarregion of the patient's wrist as shown in FIG. 22C where the gloves 2203extend over the wrist region 2220.

FIG. 23 shows another embodiment where the EDP device is configured inthe form of a hand gear 2305. The hand gear 2305 resembles a partialglove comprising an index finger wrap portion 2310, a thumb wrap portion2320 and a wrist wrap portion 2325. The hand gear 2305 has an outersurface 2315 and an inner surface (not visible) that interfaces with thepatient's skin when worn. In various embodiments, at least one EDPdevice 2300 (which may be similar to the EDP device 110, 140 or 160 ofFIGS. 1A through 1C) is located on the inner surface of the hand gear2305 such that one or more electrodes 2318 are exposed to contact thesurface of the epidermal layer of the patient. To enable visibility andfor illustration purposes, the EDP device 2300 and the one or moreelectrodes 2318 have been shown exposed, in FIG. 23, through the outersurface 2315. It should however be appreciated that the EDP device 2300,in various embodiments, lies on the inner surface of the hand gear 2305enabling only the one or more electrodes 2318 to be exposed through toallow contact with the patient's skin. In accordance with variousembodiments, the at least one EDP device 2300 is located at the wristwrap portion 2325 to stimulate the C8 dermatome on the dorsal side ofthe wrist and/or to stimulate both the C8 and T1 dermatomes on theventral side of the wrist. To stimulate both the C8 and T1 dermatomes,the EDP device is located such that its corresponding electrodesstimulate the ulnar region on the ventral side of the patient's wrist.

FIG. 24 shows another embodiment where the EDP device is configured inthe form of a ring 2405 sized to be worn on the patient's little fingeror pinky and/or the ring finger. The ring 2405 has an inner surface 2414that interfaces with the patient's skin when worn and an outer surface2415. In various embodiments, at least one EDP device 2400 (which may besimilar to the EDP device 110, 140 or 160 of FIGS. 1A through 1C) islocated on the inner surface 2414 (or alternatively embedded within thering 2405 to lie between the inner and outer surfaces 2414, 2415) suchthat one or more electrodes 2418 are exposed to contact the surface ofthe epidermal layer of the patient, when the ring 2405 is worn. The oneor more electrodes 2418 stimulate the C8 dermatome when the ring 2405 isworn on the little or ring finger by the patient. It should beappreciated that the one or more electrodes 2418 may contact thepatient's skin (on the little or ring finger) anywhere along thecircumference of the little or ring finger to stimulate the C8dermatome.

FIG. 25 shows yet another embodiment where the EDP device is configuredin the form of a squeezable toy or unit 2505 sized to be held within thehand of the patient. The squeezable toy 2505 may take any form such as,but not limited to, a ball (as shown in FIG. 25), a cylinder, an eggshaped toy or any other squeezable toy that can be held within thepatient's hand and squeezed or compressed. As shown in FIG. 25, thesqueezable toy 2505 has an outer surface 2515 that contacts thepatient's skin when the toy 2505 is held in the hand by the patient. Invarious embodiments, at least one EDP device 2500 is located on theouter surface 2515 such that one or more electrodes 2518 of the EDPdevice contact the patient's skin when the toy 2505 is held in hand bythe patient. Alternatively, the at least one EDP device 2500 may beplaced within the toy 2505 such that one or more electrodes 2518 of theEDP device are exposed through the outer surface 2515 of the toy 2505for contact with the patient's skin when the toy 2505 is held in hand bythe patient. In accordance with an aspect of the present specification,the toy 2505 is held in the hand by the patient. The one or moreelectrodes 2518 contact the C8 dermatome of the patient's palm orventral side of the hand. In one embodiment, the region exposing theelectrodes 2518 on the toy 2505 is marked or tattooed indicating thatthe patient should hold the toy 2505 such that the mark/tattoo contactsthe regions corresponding to the C8 dermatome.

In some embodiments, the one or more electrodes 2518 deliver stimulationwhen the toy 2505 is squeezed or compressed by the patient but switchoff the stimulation when the toy 2505 is relaxed or uncompressed by thepatient. Thus, repeated compression and relaxation of the squeezable toy2505 results in repeated cycles of stimulation and non-stimulation ofthe C8 dermatome. In other embodiments, the one or more electrodes 2518initiate stimulation when the toy 2505 is squeezed the first time andthereafter continue stimulation according to a pre-programmedstimulation protocol while the patient holds the toy 2505 in his hand.In still other embodiments, the one or more electrodes 2518 initiate apre-programmed stimulation protocol when the toy 2505 is held in thehand by the patient (without being compressed or squeezed). Thereafter,the patient may continue to squeeze the toy 2505 periodically withoutaffecting the application of the stimulation protocol.

FIG. 26 shows still another embodiment where the EDP device isconfigured in the form of a hand or palm gear 2605. The hand gear 2605comprises a housing 2611 having an upper or outer surface 2615 thatincludes a GUI display, for example, and a lower or inner surface (notvisible) that touches the patient's skin on the dorsal side of thepatient's hand 2606 when worn. A plurality of arms 2620 extend from thehousing 2611 to enable the hand gear 2605 to be worn and held on thepatient's hand 2606 as shown in FIG. 26. In various embodiments, the EDPdevice (not visible) is positioned within the housing 2611 such that theone or more electrodes of the EDP device are exposed through the loweror inner surface of the housing 2611 to enable contact with thepatient's skin (on the dorsal side of the patient's hand 2606) whenworn. In accordance with an embodiment, the one or more electrodesstimulate the C8 dermatome on the patient's dorsal side of the hand2606.

Thus, in accordance with some aspects of the present specification,electrical stimulation from the external surface of the patient'sepidermal layer through 10 mm or 20 mm of the dermis (using theelectro-dermal patch device 110 of FIG. 1A) provides for a non-invasivetreatment of appetite suppression, ghrelin production modulation, eatingdisorders, excessive weight or over-weight, obesity, metabolic syndromeand diabetes. In various embodiments, a stimulation depth through thepatient's epidermal layer ranges from 0.1 mm to 0.5, 1, 2, 3, 4, 5, 6,7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 mm or any incrementtherein.

Mechanisms of Action

The therapeutic objectives of the presently disclosed embodiments may beeffectuated by one or more of the following mechanisms of action. In afirst mechanism of action, the pain of hunger is negated, operatingunder one or more predefined stimulation parameters. Small diameternerve fibers carry pain stimuli through a theoretical “gate mechanism”but larger diameter nerve fibers can inhibit the transmission of painstimuli by the smaller nerves, in effect blocking or closing thistheoretical gate. It is believed that by stimulating the large nervefibers, the gate can be closed to block the pain and thereby block anysensation of hunger. In a second mechanism of action, the production ofendorphins, which are natural pain relieving hormones produced by thebody, may be upregulated or increased, operating under one or morepredefined stimulation parameters, again thereby blocking any sensationof hunger.

In a third mechanism of action, the present embodiments, operating underone or more stimulation parameters, causes a somato-somatic,somato-autonomic and/or a somato-visceral reflex with resulting afferentcentral as well as efferent visceral effects. In various embodiments,electrical stimulation from the external surface of the patient'sepidermal layer through the dermis of the dermatomes disclosed hereincreates a somatovisceral reflex with sensory nerves that connectspecifically to the stomach as an efferent pathway. As a consequence ofthis stimulation, the stomach slows down its emptying process andincreases the feeling of fullness, satiety or satiation, whichtranslates into a reduction in appetite. Similarly, in variousembodiments, electrical stimulation from the external surface of thepatient's epidermal layer through the dermis of certain dermatomes, suchas the T7 dermatome, also creates a somatovisceral reflex with sensorynerve endings to dermatome T7 as an afferent pathway and branches of thesensory nerves which stimulate the pancreatic gland as an efferentpathway.

In a fourth mechanism of action, the present application discloses amethod of modifying an individual's perception of food, or otherwiseundermining their association of positive feelings with food, andthereby increasing his or her aversion to or negative association withfood intake comprising: providing an electrical dermal patch adapted toadhere to the patient's epidermal layer, wherein said electrical dermalpatch comprises a controller, at least one electrode adapted to be inelectrical contact with said patient's epidermal layer, and a pulsegenerator in electrical communication with the controller and said atleast one electrode, defining a plurality of stimulation parameters, andprogramming the pulse generator to generate a plurality of electricalpulses using said plurality of stimulation parameters, wherein saidplurality of stimulation parameters are defined such that, afterapplying at least one stimulation to the patient's epidermal layer, thepatient has an increased aversion to food intake. In this regard, thestimulation parameters may be defined such that a) the stimulation ispainful, b) the stimulation is coordinated with, and automaticallytriggered during, the person's actual food intake times, such timesbeing programmed into the controller or pulse generator either directlyor from an external device and automatically triggering a stimulation atthe appropriate times, c) the stimulation is coordinated with, andautomatically triggered during, times of day other than the person'sactual food intake times, such times being programmed into thecontroller or pulse generator either directly or from an external deviceand automatically triggering a stimulation at such times, and d) thestimulation is manually triggered at any given time by the patient,either directly via an interface on the EDP or via the external device,as the patient may require. The benefit of this method is that itachieves, in addition to the physiological effects of appetitemodulation, the psychological effect of associating a negative sensation(electrical stimulation) with food intake, thereby undermining theotherwise positive associations the individual has with food and,therefore, one of the key psychological impetuses for compulsive eating.In this regard, the present invention achieves an aversion to foodintake, in addition to a decrease in appetite.

In accordance with an aspect, the fourth mechanism of action is agnosticof the dermatome of placement for the EDP device. In some embodiments,the user's negative association with food or the user's dissociation ofpositive feelings towards food is influenced and enhanced by timing thestimulation around meal consumption—such as substantially prior, duringand/or after meals. In various embodiments, the EDP device stimulationinfluences non-specific dermatomes, cranial nerves, cervical andlumbosacral dermatomes in order to work through this mechanism.

In a fifth mechanism of action, the presently disclosed embodimentsselectively cause electrical central nervous stimulation over electricalspinal stimulation. Electrical stimulation in the perceptive range iscentral (sensory) and in the non-perceptive range is spinal (autonomic).Electrical stimulation above a sensation reaction threshold results inselective central stimulation while electrical stimulation below thesensation reaction threshold results in selective spinal stimulation.Therefore, determining the sensation reaction threshold in a patientallows for the adjustment of electrical stimulation parameters forselective central or spinal stimulation to modulate the patient'sappetite level.

FIG. 27A is a flow chart illustrating the steps involved in oneembodiment of a method of determining stimulation reaction thresholdsand using an electro-dermal patch (EDP) device to suppress appetite in apatient. At step 2722, the EDP device is positioned on the patient'sbody. At step 2724, a central electrical stimulation reaction thresholdfor the patient is determined. Then, at step 2726, a spinal electricalstimulation reaction threshold for the patient is determined. Amicrocontroller of the EDP device is then programmed, at step 2728, suchthat at least one of a pulse width, pulse amplitude, and pulse frequencyof delivered electrical stimulation is set above the spinal electricalstimulation reaction threshold but below the central electricalstimulation reaction threshold. At step 2730, the EDP device thengenerates a plurality of electrical pulses defined by the pulse width,pulse amplitude, and pulse frequency set at step 2728.

FIG. 27B is a flow chart illustrating the steps involved in anotherembodiment of a method of determining stimulation reaction thresholdsand using an electro-dermal patch (EDP) device to suppress appetite in apatient. At step 2742, the EDP device is positioned on the patient'sbody. At step 2744, a maximum tolerable electrical stimulation reactionthreshold, which can be measured as a pain sensation, for the patient isdetermined. Then, at step 2746, a spinal electrical stimulation reactionthreshold for the patient is determined. A microcontroller of the EDPdevice is then programmed, at step 2748, such that at least one of apulse width, pulse amplitude, and pulse frequency of deliveredelectrical stimulation is set above the spinal electrical stimulationreaction threshold but below the maximum tolerable electricalstimulation reaction threshold. At step 2750, the EDP then generates aplurality of electrical pulses defined by the pulse width, pulseamplitude, and pulse frequency set at step 2748.

In a sixth mechanism of action, the electro-dermal patch (EDP) devicesof the present specification stimulate specific dermatomes as describedabove to modulate ghrelin and suppress appetite. The gastric mucosaplays a role in ghrelin-induced gastric contractions. Intrinsic primaryafferent neurons (IPAN), which comprise multi-axonal interneurons, maybe involved in passing signals from the mucosa to the myenteric plexus.Ghrelin may stimulate and modulate gastric contractions throughcholinergic, adrenergic, serotonergic, and/or opioidergic actions and/orvia nitric oxide synthase in the myenteric plexus. The stimulatoryeffects of ghrelin on gastric motility are mediated by the directstimulation of the intrinsic enteric neural pathway andcapsaicin-sensitive afferent neurons. There exists a close interactionbetween ghrelin and enteric neurotransmission, involving the stimulationof the excitatory neural system and/or the suppression of the inhibitoryneural system via ghrelin receptors, under stimulation of the intrinsicneural pathways. Ghrelin secretion during fasting is induced byadrenergic agents (locally released norepinephrine), released by neuronsacting directly on B1 receptors on ghrelin secreting cells of thestomach, resulting in fasting-induced elevation in plasma ghrelinlevels.

Stimulation at certain dermatomes, such as dermatome T6, causes asomato-visceral arc reflex which causes inhibition of the B1 adrenergicneurons that produce ghrelin. This results in a decrease in ghrelinlevels. This decrease in ghrelin causes activity in the enteric nervoussystem and intrinsic primary afferent neurons contained in the gastricmucosa (necessary as a final step in ghrelin's action on gastric andantral motility).

Therefore, in various embodiments of the present specification, the EDPdevices are believed to suppress appetite via the following mechanism.To begin, an EDP device delivers electrical stimulation to the cutaneousnerves at dermatome T6 (or any of the other dermatomes described in thepresent specification), activating the somato-visceral reflex describedabove. In some embodiments, the EDP device delivers electricalstimulation to the cutaneous nerves at dermatomes T5-T10. Stimulation ofthe B1 adrenergic plexus (neurons), which are inhibitory in nature,results in decreased production of fasting ghrelin. This leads todecreased activity in the enteric nervous system and in intrinsicprimary afferent neurons (responsible for the final steps necessary forghrelin action on gastrointestinal motility). The decreased plasmaghrelin levels result in appetite suppression as well as decreasedgastric motility and decreased gastric emptying time.

In a seventh mechanism of action, the electro-dermal patch (EDP) deviceembodiments of the present specification use electrical stimulation toeffect a reduction in antral or gastric activity resulting in a feelingof satiety over increased periods of time between meals. In oneembodiment, through the application of the right stimulation parameters,antral motility may be modulated faster than gastric emptying time.Specifically, a greater than 10% change in antral motility may beachieved after applying one electrical stimulation session while gastricemptying times only increase by more than 10% after at least 2 sessions,with no changes after just 1 session. In one embodiment, a greater than10% change in antral motility may be achieved after applying oneelectrical stimulation session while gastric emptying times onlyincrease by more than 10% after at least 2 sessions, with each sessionon a different day and all sessions occurring within one week. In oneembodiment, a greater than 10% change in antral motility may be achievedafter applying one electrical stimulation session while gastric emptyingtimes only increase by more than 10% after at least 3 sessions, witheach session on a different day and all sessions occurring within oneweek.

In another mechanism of action, the electro-dermal patch (EDP) deviceembodiments of the present specification use electrical stimulation toeffect a reduction in antral activity resulting in reduction in gastricmotility and slowing of gastric emptying. Somatic stimulation of theT2-T12 and/or C5-T1 dermatomes, using the electro-dermal patch device ofthe present specification, affects modulation of the gastrointestinalphasic pressure activity resulting in reduction in antral motility andan increase in plasma beta-endorphin levels. Thus, somatic stimulationcauses reduced post-prandial antral phasic pressure activity, slowing ofgastric emptying and therefore a feeling of satiety over increasedperiods of time between meals.

FIG. 47A is a chart 4700 illustrating mean cumulative changes (in 20minutes increments) of antral motility indices during sham stimulationsessions 4705, stimulation sessions 4710 targeted to hand dermatomes C8and/or T1 and stimulation sessions 4715 targeted to thoracic dermatomesT2-T12. Note the effect on antral motility of the hand and abdomenstimulation sessions. FIG. 47B is a chart 4701 illustrating maximumplasma endorphin levels in pg/ml related to sham stimulation sessions4706, stimulation sessions 4711 targeted to hand dermatomes C5-C8 and/orT1 and stimulation sessions 4716 targeted to thoracic dermatomes T2-T12.Note the increase in endorphin levels as a result of the hand andabdomen stimulation sessions. In additional mechanisms of action, theelectro-dermal patch (EDP) devices of the present specification useelectrical stimulation to modulate gut microbiota to improve the ratioof favorable to unfavorable gut bacteria, modulate secretions of aplurality of hormones such as serotonin, glucagon-like peptide 1 (GLP1),and leptin, reduce serum levels of lipopolysaccharide (LPS), improvemetabolic inflammation and insulin resistance, modulate restingmetabolic rate (RMR) and by improving glucose homeostasis. The specifictherapeutic objectives related to each of the above listed hormones andother physiological markers are further discussed below.

It should be appreciated that delayed gastric emptying causes improvedpost prandial glycemia and improved insulin sensitivity. Delayed gastricemptying causes food to remain in stomach for longer leading todecreased ghrelin production and therefore hunger attenuation. Thus,delayed gastric emptying delays the ghrelin cycle thereby overcoming theghrelin induced ‘urge to eat’ effect, by ghrelin level diminution, on adaily basis.

In an eighth mechanism of action, the electro-dermal patch (EDP) devicesof the present specification use electrical stimulation to effect animpairment in gastric distention/accommodation resulting in improvedsatiety, satiation and weight loss. The plurality of stimulationparameters are selected to cause at least one of: a therapeuticallysufficient amount of delay in the patient's gastric emptying time, atherapeutically sufficient amount of increase in the patient's gastricretention, and/or a therapeutically sufficient amount of impairment inthe patient's gastric distention/accommodation.

In a ninth mechanism of action, the electro-dermal patch (EDP) devicesof the present specification use electrical stimulation to effect areduction in plasma motilin resulting in a reduction in gastric motilityand improved satiety, satiation and weight loss.

In a tenth mechanism of action, the electro-dermal patch (EDP) devicesof the present specification use electrical stimulation to inhibitnitric oxide synthase around eating events (pre-eating/pre-prandial,during eating and post-eating/post-prandial) so as to maintain orincrease gastric muscle tone, impair gastric accommodation/distentionand increase gastric retention.

In some embodiments, one can measure the effects of elicitingsomatovisceral reflexes through selective dermatomal stimulation inorder to effect changes in antral pressure, antral motility, gastricemptying, satiation, satiety, ghrelin production, ghrelin circulation,GLP1, glycemia (Hemoglobin A1c), insulin, appetite, and weight (weightloss).

In accordance with some aspects of the present specification, themechanisms of action related to abdominal cutaneous dermatomalstimulation (targeting T2-T1 and preferably T5-T10 dermatomes) involveactivating somatovisceral reflexes that relay at the level of the spinalcord. Abdominal cutaneous dermatomal stimulation causes somatic andvisceral afferents to converge on the same neurons on lamina 5 of thedorsal horn of the spinal cord, and depolarize one another and exertreciprocal pre-synaptic inhibition. This inhibition causes antralmotility to decrease in both amplitude and frequency resulting indelayed gastric emptying, the feeling of satiation and satiety. Thisinhibition also produces a decrease in the production and circulation ofstomach ghrelin. The summation of these effects causes appetitesuppression and weight loss. In some embodiments, dermatomes T2-T12 andpreferably, T5-T10, are selected for somatic electrical stimulationbecause these are the spinal levels from which outflow from the uppergut arises.

In accordance with some aspects, electrical stimulation of dermatomesC5-T1 and preferably, dermatomes C8-T1, are utilized to cause the sameeffect as stimulating dermatomes T2-T12 and preferably dermatomesT5-T10. When dermatomes C5-T1 and preferably dermatomes C8-T1 areelectrically stimulated it elicits a centrally relaying somatovisceralreflex. Somatic afferent stimulation influence (in an inhibitory manner)efferents to the viscera if the entry and exit of the afferent andefferent limbs are separated by at most 2 spinal levels. DermatomesC5-T1 and preferably dermatomes C8-T1 are only separated by one spinallevel. The stimulation therapy of the present specification leveragesthis phenomenon to cause a stimulation of the somatovisceral reflexsystem resulting in inhibitory outcomes, and specifically, inhibition ofupper gastro-intestinal motility. The similarity in response betweenstimulation of dermatomes T2-T12 and preferably T5-T10 (for example, onthe trunk of the body) and dermatomes C5-T1 and preferably dermatomesC8-T1 (for example, on the wrist) demonstrates a dominance of centralover spinal relay. This is further demonstrated by similar increases inbeta endorphin levels whether electrical stimulation was performed atthe abdominal or hand level. A further indication that dermatomalelectrical stimulation of dermatomes T2-T12 and C5-T1, preferably T5-T10and C8-T1, are inhibitory in nature is that plasma levels ofnorepinephrine, epinephrine, and dopamine are not altered. Also, heartrate, systolic and diastolic blood pressure are not altered when thesedermatomes are electrically stimulated.

Conventional approaches to neuro-stimulation of the gastro-intestinalsystem to induce satiety or weight loss have typically focused on theparasympathetic nervous system (vagal nerve). The present specificationis, however, directed towards electrical stimulation of thesomatovisceral system to achieve satiety, appetite suppression, weightloss and improvement in glycemia. In other words, the mechanisms ofaction, in accordance with various aspects of the present specification,use external dermatomal stimulation to activate inhibitory pathways viathe nervous system in order to a) slow antral motility (both amplitudeand frequency) b) delay or slow down gastric emptying c) decreaseappetite and cause weight loss d) decrease ghrelin e) increase insulinf) improve glycemia (Hemoglobin A1c) g) increase gastricretention/distention and h) reduce plasma motilin.

Stimulation of the somatovisceral system via transcutaneous electricalneurostimulation of targeted dermatomes is further enhanced by targetingstimulation sessions to coincide with specific pre- and post-prandial“metabolic windows”. The pre-prandial window relates to the body'ssecretion of ghrelin just prior to anticipated eating. In someembodiments, approximately a 60 minute pre-prandial window is referredto as the “ghrelin window”. Following a meal, there is a period ofpost-prandial digestive activity lasting up to about 2 hours, which isreferred to as the “antral motility window”. In various embodiments, theEDP system of the present specification enables timing stimulationwithin or around the ghrelin window (decreasing ghrelin and therebyreducing appetite) and/or the antral motility window (decreasing antralmotility and thereby causing delayed gastric emptying and a feeling ofsatiety). These stimulation sessions can be triggered directly bypatients (manually), triggered by a preset schedule (entered by theuser, for example) or automatically triggered with reference to adetection of an eating event by a swallow detection device, such as thedevice 5605 of FIG. 56, for example, or by the eating moment recognitionmethod (FIG. 58) implemented by the HMA using a plurality of data(representing the user's food intake gestures) captured by anaccelerometer, wherein the accelerometer is included in a wrist-band orwristwatch, such as the band 2105 of FIG. 21A or the wristwatch 2106 ofFIG. 21B. In still additional embodiments, the stimulation sessions aretriggered automatically by sensors configured to detect hunger or eatingevents/signals such as, but not limited to, gut sounds, expansion ofstretch receptors.

The inhibitory mechanism of action, via the somatovisceral system, isenabled by the wearable EDP device of the present specification makingit possible to time neurostimulation sessions to coincide with specificmetabolic windows that occur around meal time throughout the day andweek.

In a yet another mechanism of action, the electro-dermal patch (EDP)device(s) of the present specification may use superficial electricalstimulation of epidermal (cutaneous) nociceptor free ending nerves whichuse the myelinated A-delta fibers to transmit signals to the spinal cord(afferent pathway). The EDP device and HMA system of the presentspecification optimize electrical stimulation of these superficialnerves in the skin causing increased tactile sensitivity (for example,tingling) however, a) without causing pain, that is without breachingthe pain threshold which in some embodiments is measured as a score on aVAS pain scale, and b) without causing involuntary skeletal musclecontractions or fasciculations (involuntary rapid flickering ofmuscles).

In accordance with still another mechanism of action, abdominalcutaneous dermatomal stimulation of T6-T7 dermatomes, using theelectro-dermal patch (EDP) device(s) of the present specification,induces improved beta cell function of the pancreas.

Method of Use of the EDP of the Present Specification for the Treatmentof Neurodegenerative Diseases

As discussed throughout the specification, transcutaneous electricalneurostimulation of certain dermatomes results in a reduction of gastricemptying time and prolongs gastric retention. Using neurostimulation toreduce gastric emptying time, optionally in conjunction with directneuromodulatory action on the sensory afferents may reduce insulinresistance and improve neurologic function in patients suffering fromneurodegenerative diseases, such as Alzheimer's disease (AD), since AD,diabetes and obesity are linked by a common dependence on insulinsignaling pathways in the central nervous system. Insulin resistance isa key factor to the development of AD pathology as insulin regulates notonly energy homeostasis, but also synaptic plasticity and memoryfunction.

Obesity is a key risk factor for developing insulin resistance. A higherlevel of fasting insulin resistance, measured with the homeostatic modelassessment of insulin resistance (HOMA-IR) is associated with a declinein cognitive ability. Delayed gastric emptying via transcutaneouselectrical stimulation of key dermatomes decreases fasting insulinresistance by at least 0.1% after a plurality of stimulation sessions.Transcutaneous electrical stimulation of dermatomes T6 and T7, amongother dermatomes and according to the disclosed embodiments, may resultin an increase in delayed gastric emptying time by 25% in overweightpatients (BMI>25), a decrease of HOMA-IR by 0.5-1, an improvement infasting insulin levels (part of the calculation used to determineHOMA-IR) by at least 15%, and a decrease in hemoglobin A1c (HbA1c) by0.5, which is 50% of the effect seem with GLP-1 receptor agonists.Accordingly, in one embodiment, a plurality of transcutaneous electricalstimulation sessions results in a therapeutic endpoint that is within30-70% of a therapeutically effective dose of glucagon-like peptide(GLP-1) receptor agonists.

Positive therapeutic results may also be achieved by applyingtranscutaneous electrical stimulation, in accordance with the disclosedembodiments, to treat Parkinson's disease (PD). Lowering HOMA-IR viastimulation of key dermatomes, such as dermatomes T6, would reduceextracellular accumulation of Aβ in plaques, the deposition of which isa key pathologic driver of AD. In addition, patients may see an increasein cerebral blood flow. Patients may see an increase of 15% in regionalglucose metabolism. PD patients treated with transcutaneous electricalstimulation will show an improvement in “motor” and “non-motor” diseasemeasures including cognition. Motor symptoms include bradykinesia,tremor, rigidity, and gait and postural disturbances and are typicallymeasured by the Unified Parkinson's Disease Rating Scale (UPDRS partIII) or Movement Disorder Society sponsored revision of the UnifiedParkinson's Disease Rating Scale (the MDS-UPDRS-III).

Positive therapeutic results may also be achieved by applyingtranscutaneous electrical stimulation, in accordance with the disclosedembodiments, to treat Alzheimer's disease (AD). Cognitive gains inpatients with AD can be assessed by multiple methods (in addition toformal neuropsychological testing). The Mini Mental Status Exam (MMSE)is one of the most widely used and validated bedside instruments formental status evaluation. The Mattis Dementia Rating Scale (DRS), whichyields a total DRS score, is a reliable and clinically useful measure ofmental status in patients with AD. A score cutoff of less than 120 canbe used to identify dementia. The DRS-2 is the more recent version ofthe DRS and is a frequently used assessment of cognitive status amongolder adults in both a clinical and research setting. Transcutaneouselectrical stimulation, in accordance with the embodiments disclosedherein, would exhibit an average improvement in the treatment group ofat least 2.5 points in the DRS-2 over 1 year, compared withdeterioration in control patients.

Alternative scales which are appropriate tools to monitor dementiaprogression include the Severe Impairment Battery (SIB), the modified19-item AD Cooperative Study—Activities of Daily Living Inventory(ADCS-ADL19), the Clinician's Interview-Based Impression of Change PlusCaregiver Input (CIBIC-Plus), the Neuropsychiatric Inventory, and theBehavioral Rating Scale for Geriatric Patients (BGP Care DependencySubscale). Additional testing which may show benefit comes from theMontreal Cognitive Assessment (MoCA), which is a brief cognitiveassessment capable of identifying specific memory deficits. Finally, theWechsler Memory Scale (WMS-IV) is an effective tool for evaluatingcognition via tests of orientation, time estimation, mental control,clock drawing, incidental recall, inhibition, and verbal reproduction.Transcutaneous electrical stimulation, in accordance with theembodiments disclosed herein, would exhibit an improvement in thetreatment group as measured using any of the aforementioned scales.

By using electrical neurostimulation of certain key dermatomes, patientsmay see a combination of improved insulin resistance as measured byHOMA-IR, modification of amyloid burden, regional brain glucosemetabolism, and direct action by sensory afferent stimulation, resultingin improvement of cognitive function.

Stimulation Patterns/Protocols to Drive Therapy

As discussed earlier, the user's plurality of health relatedinformation, such as the user's hunger profile, standard eating andmeals profile, actual eating and meals profile, energy balance, weighttrends, glucose data, stimulation induced nausea, dyspepsia andhabituation events, are used by the Health Management application tosuggest and/or implement a plurality of recommendations comprisingstimulation patterns or protocols, medication (such as an amount ofinsulin intake, for example), dietary and/or activities plans. It shouldbe appreciated that this integrated system provides users with a degreeof independence and encourages patient compliance. Notwithstanding theabove, however, the present application does apply to having physiciansset or modify the stimulation protocols, either directly programming theEDP, programming the EDP through the companion device, or remotelycommunicating a desired protocol from a remote server or third partycomputing device to either the EDP directly or via the companion device.

In various embodiments, recommendations related to stimulation patternsor protocols comprise driving, setting, customizing or adjusting aplurality of stimulation parameters such as, but not limited to, thenumber of stimulation sessions per day; duration of each stimulation;time or moment of application of the stimulation sessions; intensity ofstimulations, stimulation pulse shape, frequency, width and amplitude;stimulation duty cycle; stimulation continuity profile; minimum andmaximum overall duration or course of stimulation treatment in days,weeks or months. Following are exemplary standard setting ranges forsome of the stimulation parameters:

-   -   Pulse Width: 10 μsec to 10 msec    -   Pulse Amplitude: 100 μA to 500 mA, less than 60 mA, 100 μA to        100 mA, 100 μA to 500 mA, 1 mA to 30 mA, 15 mA to 30 mA, 5 mA to        45 mA, and any increment therein in the aforementioned ranges    -   Pulse Frequency: 1 Hz to 10,000 Hz, preferably 1 Hz to 100 Hz        and preferably 1 Hz to 100 Hz with no other frequencies greater        than 100 Hz included in the stimulation signal    -   Pulse Shape: Monophasic, biphasic, sinusoidal    -   Duty Cycle: 1% to 100% calculated on a weekly basis    -   Stimulation Session Duration: lmin to 120 min or 50 ms to 120        min or substantially continuously    -   Number of Stimulation Sessions/Day: 1 to 24    -   Number of Sessions/Week: 1 to 168 or 1 to substantially        continuously    -   Daily Pre-Prandial Stimulations: half hour to an hour prior to        each meal every day, as most patients typically report hunger        peaking just prior to meals    -   Burst Mode (a burst of programmable pulses at a rate): 0.1 Hz to        100 Hz    -   Ramp Up/Down Mode (the time it takes to go from no stimulation        to a peak or steady state (Ramp Up) and the time it takes to go        from peak or steady state stimulation to no stimulation (Ramp        Down)): 0.1 sec to 60 sec    -   Modulated Mode: Range between 1%-100% amplitude, modulating        up/down over a period of 0.1 sec-60 sec; modulation can be        linear or sinusoidal; that is, in “modulated mode” the amplitude        varies between 1% and 100% of a target amplitude (such as 10 mA)        and this amplitude variation occurs over a period of 0.1 seconds        to 60 seconds    -   Electrode impedance (the electrode-tissue interface impedance):        100 ohms to 5 kilo-ohms, 10 ohms to 5 kilo-ohms, 200 ohms to        1000 ohms, 500 ohms to 1000 ohms, or 1 kilo-ohms to 100        kilo-ohms

In embodiments, a duty cycle of stimulation is optimized or adjustedsuch that the EDP device remains in sleep mode between consecutivestimulation sessions that correspond to an active mode of the EDPdevice. In various embodiments, the sleep mode corresponds to an averagecurrent of less than 10 μA while the active mode corresponds to anaverage current range of 2 to 30 mA.

In some embodiments, the electro-dermal patch device provides electricalstimulation having the following parameters which are adjustable by thepatient using the companion device:

-   -   Monophasic pulse shape with an active charge balancing phase    -   Pulse Width: 25 μsec to 400 μsec in steps of 25 μsec    -   Pulse Amplitude: 1 mA to 50 mA in steps of 1 mA    -   Pulse Frequency: from 1 Hz, 5 Hz, 10 Hz, 15 Hz, 20 Hz, 25 Hz, 30        Hz, 40 Hz, 50 Hz, 60 Hz, 70 Hz, 80 Hz, 90 Hz, 100 Hz, 150 Hz,        200 Hz    -   Stimulation Session Duration: from 5 min to 60 min in steps of 5        min

In some embodiments, the electro-dermal patch device provides electricalstimulation having the following parameters which are adjustable by thepatient using the companion device:

-   -   Pulse Width: 100 μsec to 500 msec, preferably 10 μsec to 100        msec    -   Pulse Amplitude: 1 μA to 1 mA    -   Pulse Frequency: 0.1 Hz to 1 kHz    -   Stimulation Session Duration: 1 min to 24 hr    -   Number of Stimulation Sessions/Day: 1 to 24    -   Number of Sessions/Week: 1 to substantially continuously

In various embodiments, the plurality of stimulation parameters arechosen or set to cause at least one of: a therapeutically sufficientamount of delay in the patient's gastric emptying time, atherapeutically sufficient amount of increase in the patient's gastricretention, a therapeutically sufficient amount of impairment in thepatient's gastric distention/accommodation, a therapeutically sufficientamount of reduction in the patient's plasma motilin.

In one embodiment, the electrical pulses, whether in a single waveformor multiple waveforms, only have a frequency of up to 200 Hz and nogreater. In other words, the system does not deliver any electricalpulse that has a frequency in excess of 200 Hz. In another embodiment,the electrical pulses are delivered in a single waveform and do not takethe form of multiple waveforms integrated or combined together.

In various embodiments, the electro-dermal patch device, being wearable,enables providing electrical stimulation more frequently than one dayper week. Also, the stimulation parameters and protocols are programmedto be therapeutically effective without triggering habituation, nauseaand/or dyspepsia. Accordingly, in some embodiments, the amount ofelectrical stimulation delivered is equal to or greater than energyequivalent of 30 minutes per day at an amplitude of 20 mA (or equals,say, 10 mA hours=10 mA×60 minutes of energy equivalent) but less than240 mA hours per day (that is less than, say, 12 hours at 20 mA, 6 hoursat 40 mA or 24 hours at 10 mA), with the delivered amount includingevery energy increment between the minimum and maximum amounts. In otherembodiments, a minimum amount of electrical stimulation delivered is anenergy equivalent of 5 minutes per day at 10 mA, whereas a maximumamount of electrical stimulation delivered is an energy equivalent of 12hours per day at 30 mA, with the delivered amount including every energyincrement between the minimum and maximum amounts. In accordance withsome embodiments, a weekly minimum amount of electrical stimulationdelivered is an energy equivalent of 30 minutes per day at 10 mAdelivered 3 days per week (which for a patient's minimum estimated skinresistance of 400 Ohms is equal to about 5 Joules per session or 15Joules per week), whereas a weekly maximum amount of electricalstimulation delivered is an energy equivalent of 24 hours per day at 30mA delivered 7 days per week (which for a patient's maximum estimatedskin resistance of 1000 Ohms is equal to about 44,000 Joules per week),with the delivered amount including every energy increment between theminimum and maximum amounts. In an alternate embodiment, the weeklymaximum amount of electrical stimulation delivered is an energyequivalent of 12 hours per day at 45 mA delivered 7 days per week. Inanother embodiment, a weekly minimum amount of electrical stimulationdelivered is 60 Joules with two stimulation sessions of 30 Joules perstimulation at 20 mA, whereas a weekly maximum amount of electricalstimulation delivered is 13,000 Joules with 12 hours of stimulation at20 mA for 7 days, with the delivered amount including every energyincrement between the minimum and maximum amounts. It should beappreciated that any of the aforementioned maximums may be combined withany of the aforementioned minimums, with the delivered amount includingevery energy increment between the minimum and maximum amounts.

Table Z illustrates the energies delivered to a patient for stimulationtherapy ranging from 30 minutes per day to 12 hours per day, atprogrammed parameters of pulse amplitude of 20 mA, pulse width of 200μSec, frequency of 20 Hz wherein the patient's skin resistance isestimated to be 650 Ohms (skin resistance ranges from 400 to 1000 Ohms)in accordance with an embodiment.

TABLE Z Parameters Value Unit Current (I) 20 mA Pulse Width (w) 200 μSecFrequency (F) 20 Hz Resistance (R) (estimated) 650 Ohms Pulse Power (P =I² × R) 0.26 Watts Pulse Duty Cycle (D = w × 20) 0.004 Power Second (J =P × D × F) 0.0208 W-sec (Joules) Stimulation energy for various timeintervals Time Interval (T₁) 30 minutes Energy delivered (E = J × T₁)37.44 Joules/30 Minutes Time Interval (T₂) 12 Hours Energy delivered (E= J × T₂) 898.56 Joules/12 Hours

In some embodiments, the electro-dermal patch device provides a constantbasal rate of electrical stimulation having the following parameterswhich are adjustable by the patient using the companion device. In someembodiments, the electro-dermal patch device provides electricalstimulation timed around meals and having the following parameters whichare adjustable by the patient using the companion device:

-   -   Daily Pre-Prandial Stimulations: at least one minute to two        hours prior to each meal (breakfast, lunch and dinner) every        day, as most patients typically report hunger peaking just prior        to meals.    -   Daily During Meal or Post-Prandial Stimulations: during        consumption of each meal immediately or at least one minute to        120 minutes after consumption of each meal.

In accordance with aspects of the present specification, stimulationsessions are timed to coincide with pre- and post-prandial “metabolicwindows”. The pre-prandial window relates to the body's secretion ofghrelin just prior to anticipated or scheduled eating. It should beappreciated that an individual has a ghrelin profile comprising aplurality of peaks or maximum levels of ghrelin plasma concentration anda plurality of valleys or minimum levels of ghrelin plasma concentrationdistributed over a time span of 24 hours. The plurality of peaks ormaximum levels of ghrelin plasma concentration typically correspond toanticipated or scheduled meal timings—such as breakfast, lunch anddinner. In accordance with various aspects of the present specification,a pre-prandial window begins with an increase or surge in ghrelin plasmaconcentration and reaches a zenith with peaking of ghrelin plasmaconcentration near anticipated or scheduled meal timings. In someembodiments, approximately a 60 minute pre-prandial window is referredto as a “ghrelin window”. In various embodiments, a stimulation sessionis timed to occur within the ghrelin window, wherein the stimulationsession is initiated when the ghrelin plasma concentration is withinrange of the maximum acceptable level of ghrelin plasma concentration.Stimulation during the ghrelin window results in decreasing ghrelinplasma concentration and thereby reduced appetite or readiness to eat.

The post-prandial window relates to the body's incrementally decreasingsecretion of ghrelin during and/or after consumption of a meal. Inaccordance with various aspects of the present specification, thepost-prandial window begins during and/or after culmination ofconsumption of a meal and reaches a nadir corresponding to minimumlevels of ghrelin plasma concentration. Thus, in some embodiments,following a meal there is a period of post-prandial digestive activitylasting about 1 hour to 2 hours, which is referred to as an “antralmotility window”. In various embodiments, a stimulation session is timedto occur within the antral motility window, wherein the stimulationsession is terminated when the ghrelin plasma concentration is withinrange of the minimum acceptable level of ghrelin plasma concentration.Stimulation during the antral motility window results in decreasingantral motility thereby causing delayed gastric emptying and a feelingof satiety.

In an embodiment, a baseline stimulation scheme or protocol is set at 3daily stimulation sessions of 15 minutes each having a pulse amplitudeof 20 mA timed pre-prandial and 60 minutes each having a pulse amplitudeof 20 mA timed post-prandial, that is immediately prior to commencementand upon completion of each meal such as breakfast, lunch and dinner. Inother words, the baseline stimulation scheme or protocol comprises3×1.25 hours=3.75 hours total (15 minutes pre-prandial to each meal and60 minutes post prandial). In some embodiments, the base line pulseamplitude ranges from 5 mA to 10 mA to enable total stimulationdurations that are longer than 3.75 hours. In various embodiments, thesepre-prandial and post-prandial stimulation sessions are triggeredmanually by the user (in response to scheduled prompts, for example). Insome alternate embodiments, the pre-prandial and post-prandialstimulation sessions are automatically triggered based on pre-storedmeal time schedule or calendar, daily diary inputs (such as, but notlimited to, weight), historic record of hunger events and/or othereating related events (such as, for example, unscheduled eating events).In some alternate embodiments, the post-prandial stimulation sessionsare automatically triggered with reference to a detection of an eatingevent by a swallow detection device, such as the device 5605 of FIG. 56,or by the eating moment recognition method (FIG. 58) implemented by theHMA using a plurality of data (representing the user's food intakegestures) captured by an accelerometer, wherein the accelerometer isincluded in a wrist-band or wristwatch, such as the band 2105 of FIG.21A or the wristwatch 2106 of FIG. 21B. In further alternateembodiments, the baseline stimulation scheme or protocol ispre-programmed by either factory setting or by the physician while theuser can only schedule timing of mealtimes.

It should be appreciated that any initial, baseline or defaultstimulation parameters, which are implemented upon starting the deviceand without the benefit of any user input regarding their appetite,hunger, satiety level, satiation level, fullness level, well-beingstatus, nausea status or other information, may be universally fixed forall persons or may be based upon any one or a combination of thefollowing parameters of the person: age, gender, ethnicity, weight, bodymass index, body fat percentage, and/or race. Therefore, stimulationdosing may be initially based on categorizing the individual into one ormore template groups and choosing a corresponding protocol. For example,one may classify individuals into various groups (a BMI greater than 40,a BMI of 35 to 39, a BMI of 30 to 34, and a BMI of 25 to 29) and apply astandard or baseline stimulation scheme for all individuals within thatclassification. The same could apply to a combination of age and genderfor example (females 65 and over, females 55 to 64, females 45 to 54,females 35 to 44, females 25 to 34, females 24 and under, males 65 andover, males 55 to 64, males 45 to 54, males 35 to 44, males 25 to 34,males 24 and under). Additionally, the initial stimulation settings maybe based on any parameters indicative of the patient's extent ofappetite, or hunger, satiety level, satiation level, or fullness level.

It should further be appreciated that any selected stimulationparameters may be titrated for a given patient. Specifically, they maybe adjusted upward or downward based on the amount of stimulation feltby the patient and/or immediately reported feelings of pain, nausea, orother discomfort.

In some embodiments, the stimulation continuity profile may be, for eachstimulation session duration the stimulation profile applied,continuous; intermittent including short intervals of Y seconds of nostimulation; step-up stimulation wherein the stimulation amplitudeand/or frequency increases at a predefined rate from commencement tocompletion of a stimulation session duration; or step-down stimulationwherein the stimulation amplitude and/or frequency decreases at apredefined rate from commencement to completion of a stimulation sessionduration. In some embodiments, the stimulation continuity profile mayvary on a day to day basis. For example, for a treatment duration of,say, 4 weeks the stimulation profile applied may be at least one ofcontinuous wherein the number and/or intensity of stimulation does notvary throughout the treatment; step-up stimulation wherein the intensityand number of sessions per day increase at a predefined rate on a dailyor weekly basis; step-down stimulation wherein the intensity and numberof sessions per day decrease at a predefined rate on a daily or weeklybasis.

In accordance with an aspect, the stimulation energy delivered to thepatient, in each stimulation session, can be increased or decreased bymodifying either of the stimulation pulse amplitude or the stimulationpulse width. In an embodiment, both the pulse width and pulse amplitudemay be modified.

In one embodiment, the stimulation pulse width is changed while thepulse amplitude is kept constant. For example, the pulse width may bemodified within a range of, say, 50 μsec to 400 μsec in steps of 25 μsecwhile the pulse amplitude ranges from 10 mA to 200 mA, or any incrementthereof. In an embodiment, the pulse amplitude is fixed at, for example,50 mA (assuming a 500 ohm load). The waveform shape is chosen to bemonophasic with charge balancing. In the embodiment where pulse widthmay be increased while the pulse amplitude is fixed, the number ofnausea episodes may increase.

In another embodiment, the stimulation pulse amplitude is changed whilethe pulse width is kept constant. For example, the pulse amplitude maybe modified within a range of, say, 100 μA to 500 mA while the pulsewidth is fixed at, say, 100 μsec. The waveform shape may remainmonophasic with charge balancing.

It should be noted herein that the pulse amplitude range may beelectrode dependent. In an embodiment, the electrode-skin interfaceimpedance (function of electrode design and skin type) determines thisrange, as well as the target nerves for stimulation (or inhibition).

In accordance with an aspect of the present specification, the target orfull pulse amplitude for a stimulation session is not delivered orreached immediately or instantly at the start of the stimulation sessionrather, in various embodiments, the pulse amplitude is graduallyincreased or ramped up to reach the target pulse amplitude over apredefined period of time. For example, the baseline pulse amplitude of20 mA, in a stimulation session, is reached gradually over a predefinedperiod of time (such as, say, 1 minute) starting from zero or very lowpulse amplitude such as, say, 5 mA. This is advantageous in that animmediate or instant delivery of 20 mA pulse amplitude may startle andcause discomfort to the user whereas a gradual pulse amplitude ramp-upprofile of the present specification will enable the user to getaccustomed to the electrical energy to be delivered and prevent anyshock or alarm due to an initial spike of pulse amplitude exposure.

In some embodiments, the time or moment of application of stimulationsessions may be, for example, ‘t’ minutes before meals such asbreakfast, lunch, snack, dinner, wherein T is within a range of 1 min to150 min; right before going to bed; at the onset of hunger and/or rightbefore an expected hunger event based on the user's recorded hungerprofile.

In accordance with an embodiment, a stimulation scheme or protocol isset at 3 daily stimulation sessions of 30 minutes each (3×30 minutes perday) timed post-prandial (that is, for example, after breakfast, lunchand dinner).

In accordance with aspects of the present specification, the EDP devicedelivers stimulation therapy over prolonged periods of time while at thesame time ensuring minimization of skin irritation or rashes.

When the user's skin is exposed to electrical stimulation eachelectrical pulse not only induces a nerve conduction reaction but alsodrives a chemical reduction-oxidation (redox) reaction. The redoxreaction generates ions which, if left to build up, negatively affectsthe pH of local tissue, creates acidity, and causes skin irritation.

FIG. 73 shows a first waveform 7305 which is a monophasic waveform, asecond waveform 7310 representing a symmetrical, biphasic,charge-balanced waveform, a third waveform 7315 indicative of anasymmetrical, biphasic, charge-balanced waveform and a fourth waveform7320 illustrating a spike-like biphasic waveform or pulse. Consider themono-phasic pulse 7305, such as a square wave with a positive wave thatgoes up and back down to a baseline. If such a wave is applied, it willinduce a nerve reaction but it will also drive a redox reaction in onedirection, generating an increased number of ions over time. Nowconsider changing that mono-phasic pulse 7305 to biphasic (for example,waveform 7310 or 7315), such as a square wave that is positive, whichthen becomes negative and then returns back to baseline. In this case,one is inducing a nerve reaction with each wave, however, by changingthe wave phase, the redox reaction is reversed. Accordingly, while thepositive wave may drive the redox reaction forward, the negative wavedrives the redox reaction in reverse, thereby reducing the generation ofions.

The symmetrical, biphasic, charge-balanced waveform starts at abaseline, rapidly increases to a peak current with a first current rampslope greater than one and approaching an undefined, vertical value,plateaus at that peak current for a period of time, T1, rapidlydecreases to baseline with a second current ramp slope less thannegative one and approaching an undefined, vertical value, rapidlydecreases to a negative current value at the same second current rampslope or a negative first current ramp slope, plateaus at that currentfor a period of time T2, and rapidly increases to baseline with anegative second current ramp slope or the first current ramp slope. Theasymmetrical, biphasic, charge-balanced waveform starts at a baseline,rapidly increases to a peak current with a first current ramp slopegreater than one, plateaus at a peak current and decays thereafter for aperiod of time, T1, rapidly decreases to baseline with a second currentramp slope less than negative one, rapidly decreases to a negativecurrent value at a third current ramp slope less than negative one,plateaus at that current, and rapidly increases to baseline with apositive fourth current ramp slope, where the first, second, third, andfourth current ramp slopes are all different or where at least one ofthe first and third and the second and fourth current ramp slopes aredifferent.

In various embodiments, the stimulation sessions of the presentspecification comprise charge-balanced, biphasic symmetrical orasymmetrical waveform or current pulses 7310, 7315. In other words, invarious embodiments, the EDP device generates pulse to pulse flippedsymmetrical or asymmetrical, biphasic, charge-balanced waveform orpulses 7310, 7315. The waveform is driven by an algorithm that stops atpredefined time interval (for example after every 5 minutes, and allowsthe skin to rest from 1 to 2 minutes) and then continues until aprescribed therapy time. The predefined time interval can also be arandomized value, in various embodiments, so as to not create skinfatigue. In embodiments, the waveform is further characterized by arapid attainment of a peak amplitude followed by an almost instantaneousdrop in the amplitude.

While the negative wave in the waveforms 7310, 7315 will reverse theredox reaction, the reduction or elimination of ions will not be at100%. It will be more in a range of 90%. In some embodiments, iongeneration is further reduced by at least one of: 1) generating abiphasic pulse—such as the symmetric or asymmetric waveforms 7310, 7315;and, optionally, 2) following a first pulse with a second pulse, whereinthe second pulse is same as the first pulse except that the phase of thesecond pulse is reversed with respect to the first pulse.

FIG. 74A illustrates first and second consecutive symmetric biphasicpulses 7405, 7410 where the phase or polarity of the second pulse 7410is reversed with reference to the first pulse 7405 and there is apredefined time interval or wait time 7407 between the pulses 7405,7410.

FIG. 74B illustrates first and second consecutive asymmetric biphasicpulses 7415, 7420 where the phase or polarity of the second pulse 7420is reversed with reference to the first pulse 7415 and there isoptionally a predefined time interval or wait time 7417 between thepulse 7415, 7420. In each of the cases of FIGS. 74A, 74B, the negativepulse 7405 n, 7415 n of the respective first biphasic pulses 7405, 7415reverses most of the redox reaction and the negative pulse 7410 n, 7420n of the respective second biphasic pulses 7410, 7420 continues thereversal, extending the reaction further and thereby making sure thatmore of the redox reaction is reversed before creating more ions.

In some embodiments, an amplitude of the first phase, the second phase,the third phase, and the fourth phase are equal and a pulse width of thefirst phase, the second phase, the third phase, and the fourth phase areequal.

In some embodiments, the predefined time interval is in a range of 1minute to 10 minutes.

Therefore, by applying the train of pulses of FIG. 74A or 74B to twoelectrodes, left and right, of an EDP device of the presentspecification: a) a positive pulse is applied to the left electrodewhile a negative pulse is applied to the right electrode; b) a negativepulse is immediately applied to the left electrode, while a positivepulse is applied to the right electrode; c) there is preferably a waittime between pulses where no stimulation is occurring; d) a negativepulse is then applied to the left electrode while a positive pulse isapplied to the right electrode; and e) a positive pulse is applied tothe left electrode while a negative pulse is applied to the rightelectrode. It should be appreciated that the term phase refers to aportion of the waveform having a consistent polarity, either positive ornegative, and the term polarity refers to the negative or positivestimulation state of the pulse.

FIG. 74C illustrates, in accordance with alternate embodiments, firstand second consecutive symmetric biphasic pulses 7425, 7430 where thephase or polarity of the second pulse 7430 is reversed with reference tothe first pulse 7425 and there is a predefined time interval or waittime 7427 between the pulse 7425, 7430. As shown in FIG. 74C, thepositive pulse 7425 p of the first biphasic pulse 7425 is followed by apositive pulse 7430 p of the second biphasic pulse 7430.

FIG. 74D illustrates, in accordance with alternate embodiments, firstand second consecutive asymmetric biphasic pulses 7435, 7440 where thephase or polarity of the second pulse 7440 is reversed with reference tothe first pulse 7435 and there is optionally a predefined time intervalor wait time 7437 between the pulse 7435, 7440. As shown in FIG. 74D,the positive pulse 7435 p of the first biphasic pulse 7435 is followedby the positive pulse 7440 p of the second biphasic pulse 7440. In eachof the cases of FIGS. 74C, 74D, the positive pulse 7425 p, 7435 p of therespective first biphasic pulses 7425, 7435 reverses most of the redoxreaction and the positive pulse 7430 p, 7440 p of the respective secondbiphasic pulses 7430, 7440 continues the reversal, extending thereaction further and thereby making sure that more of the redox reactionis reversed before creating more ions.

In some embodiments, an amplitude of the first phase and the fourthphase are equal, a pulse width of the first phase and the fourth phaseare equal, an amplitude of the second phase and the third phase areequal, wherein a pulse width of the second phase and the third phase areequal, and wherein at least one of the amplitude and the pulse width ofthe first phase is different from the amplitude and pulse width of thesecond phase.

In some embodiments, the first phase is defined by a waveformcharacterized by a first period and a second period, wherein the firstperiod comprises a first 10 μs of the waveform and the second periodcomprises a remainder of the waveform and wherein said waveform isdefined by a maximum amplitude during the first period and an amplitudeless than said maximum amplitude during the second period.

In some embodiments, at least one of the first phase, second phase,third phase, and fourth phase is defined by a waveform characterized bya first period, a second period, and a third period, wherein the firstperiod comprises at least a portion of 0 to 10 μs of the waveform, thesecond period comprises at least a portion of 10 μs to 100 μs of thewaveform, and the third period comprises at least a portion of 100 μs to200 μs of the waveform, wherein the first period is defined by a maximumamplitude and the second and third periods are defined by a remainderamplitude less than said maximum amplitude.

By applying the train of pulses of FIG. 74C or 74D to two electrodes,left and right, of an EDP device of the present specification: a) anegative pulse is applied to the left electrode while a positive pulseis applied to the right electrode; b) a positive pulse is immediatelyapplied to the left electrode, while a negative pulse is applied to theright electrode; c) there is preferably a wait time between pulses whereno stimulation is occurring; d) a positive pulse is then applied to theleft electrode while a negative pulse is applied to the right electrode;and e) a negative pulse is applied to the left electrode while apositive pulse is applied to the right electrode. It should beappreciated that the term phase refers to a portion of the waveformhaving a consistent polarity, either positive or negative, and the termpolarity refers to the negative or positive stimulation state of thepulse.

FIG. 75A is a flowchart illustrating a plurality of steps of generatinga train of biphasic pulses, in accordance with embodiments of thepresent specification. At step 7505, an EDP device with two electrodes,left and right, generates a biphasic charge-balanced train of pulses(such as the train of pulses of FIGS. 74A, 74B). The pulses aresymmetric or asymmetric in various embodiments. Also, the train ofpulses is characterized in that any two consecutive first and secondpulses (of the train of pulses) are reversed in terms of their phaseswith reference to one another.

At step 7510, the first pulse is applied to the left and rightelectrodes of the EDP device. At step 7515, the left electrode receivesa positive pulse while the right electrode receives a negative pulse. Atstep 7520, the left electrode immediately receives a negative pulsewhile the right electrode receives a positive pulse. At step 7525, thereis a predefined wait time before the second pulse, consecutivelyfollowing the first pulse, is received at the electrodes. At an end ofthe wait time, at step 7530, the second pulse is applied to the left andright electrodes of the EDP device. At step 7535, the left electrode nowreceives a negative pulse while the right electrode receives a positivepulse. Finally, at step 7540, the left electrode immediately receives apositive pulse whereas the right electrode receives a negative pulse.

Thus, in some embodiments, the first electrical pulse is defined by afirst phase having a first polarity and a second phase having a secondpolarity that is opposite the first polarity, wherein the secondelectrical pulse follows the first electrical pulse and is defined by athird phase having a third polarity and a fourth phase having a fourthpolarity that is opposite the third polarity, and wherein the secondpolarity is equal to the third polarity. In some embodiments, the firstpolarity is positive, the second polarity is negative, the thirdpolarity is negative, and the fourth polarity is positive.

FIG. 75B is a flowchart illustrating a plurality of steps of generatinga train of biphasic pulses, in accordance with embodiments of thepresent specification. At step 7545, an EDP device with two electrodes,left and right, generates a biphasic charge-balanced train of pulses(such as the train of pulses of FIGS. 74C, 74D). The pulses aresymmetric or asymmetric in various embodiments. Also, the train ofpulses is characterized in that any two consecutive first and secondpulses (of the train of pulses) are reversed in terms of their phaseswith reference to one another.

At step 7550, the first pulse is applied to the left and rightelectrodes of the EDP device. At step 7555, the left electrode receivesa negative pulse while the right electrode receives a positive pulse. Atstep 7560, the left electrode immediately receives a positive pulsewhile the right electrode receives a negative pulse. At step 7565, thereis a predefined wait time before the second pulse, consecutivelyfollowing the first pulse, is received at the electrodes. At an end ofthe wait time, at step 7570, the second pulse is applied to the left andright electrodes of the EDP device. At step 7575, the left electrode nowreceives a positive pulse while the right electrode receives a negativepulse. Finally, at step 7580, the left electrode immediately receives anegative pulse whereas the right electrode receives a positive pulse.

Thus, in some embodiments, the first electrical pulse is defined by afirst phase having a first polarity and a second phase having a secondpolarity that is opposite the first polarity, wherein the secondelectrical pulse follows the first electrical pulse and is defined by athird phase having a third polarity and a fourth phase having a fourthpolarity that is opposite the third polarity, and wherein the secondpolarity is equal to the third polarity. In some embodiments, the firstpolarity is negative, the second polarity is positive, the thirdpolarity is positive, and the fourth polarity is negative.

As shown in FIG. 61, in an embodiment, each of the 3 daily stimulationsessions delivered has a pulse waveform 6100 with the followingcharacteristics or parameters:

-   -   Maximum Compliance Voltage: 45 Volts (can range from 40 Volts to        60 Volts in various embodiments)    -   Pulse Amplitude: 30 mA (can be any one of 20 mA, 30 mA or 40 mA        in various embodiments)    -   Pulse Width: 200 μsec    -   Pulse Frequency: 30 Hz (can be any one of 20 Hz, 30 Hz or 40 Hz        in various embodiments)    -   Waveform: biphasic (charge balanced)

With the EDP electrodes impedance ranging from 300 ohms to 1000 ohms anddue to the patient's skin resistance, the waveform 6100 immediatelyattains a peak amplitude value 6105 at the beginning. The peak amplitudevalue 6105 ranges from 25 mA to 30 mA, in some embodiments, and rangesfrom 20 mA to 50 mA in other embodiments. The peak amplitude value 6105deteriorates almost instantaneously to a first amplitude value 6110 in afirst time period 6115. In embodiments, the first amplitude value 6110ranges from 20 mA to 22 mA and the first time period 6115 is 80 μsec.Thereafter, the waveform 6100 deteriorates even further during a secondtime period 6120 to attain a second amplitude value 6125. Inembodiments, the second time period 6120 is 120 μsec and the secondamplitude value 6125 ranges from 4 mA to 8 mA. Essentially, the waveform6100 behaves as a waveform equivalent to one with an average amplitudeof 18 mA across the first and second time periods. In the embodiment,the sum of the first and second time periods 6115, 6120 is 200 μsec.Also, while in the present embodiment the first time period 6115 isabout 40% (that is, 80 μsec) of the total pulse width (that is, 200μsec) in other embodiments the first time period may range from 5% to95%, where the maximum and minimum may be any increment therein, of thepulse width.

It should be appreciated that the quick deterioration of the peakamplitude value 6105 to the first amplitude value 6110 in the first timeperiod 6115 and to the second amplitude value 6125 in the remainingsecond time period 6120 imparts a sharp tingling perception or feel tothe waveform in the beginning that reduces subsequently. In someembodiments, the waveform may attain the peak amplitude value 6105immediately and then quickly deteriorate to the lower amplitude value of6125 (without first deteriorating to the first amplitude value 6110).While in one embodiment, of FIG. 61, the pulse waveform has a pulseamplitude of 30 mA and a frequency of 30 Hz, in alternate embodimentsthe pulse amplitude may be 20 mA or 40 mA and the frequency may be 20 Hzor 40 Hz. In one preferred embodiment, the waveform 6100 ischaracterized by a peak amplitude of 40 mA, a pulse frequency of 30 Hzand a pulse width of 200 μsec.

The sharp tingling feeling is characteristic of the stimulation therapyof the present specification, compared to prior art TENS devices, and isattributable to the waveform parameters, such as those of the waveform6100, an upper compliance voltage limit of 45 Volts coupled with lowskin impedance of below 1000 ohms for the electrodes of the EDP deviceof the present specification. Prior art TENS devices tend to use highvoltages such as those at or above 80 Volts. It should be appreciated,that capping or limiting the voltage at 45 Volts for the EDP device ofthe present specification coupled with the waveform 6100 enables aunique stimulation footprint and a unique patient sensation that avoidsthe vibrations and muscle spasm typically generated by conventional andprior art TENS units operating at similar amplitudes.

In another embodiment, the waveform 6100 is characterized by: a maximumcompliance voltage in a range of 40 volts to 60 volts, a peak amplitudevalue 6105 in a range of 20 to 50 mA, a first time period 6115 of 10 μswhile the second time period 6120 comprising a remainder of thewaveform, average amplitude across the first and second time periods isin a range of 10 mA to 30 mA.

In yet another embodiment, the waveform is characterized by a first timeperiod, a second time period, and a third time period, wherein the firstperiod comprises at least a portion of 0 to 10 μs of the waveform, thesecond period comprises at least a portion of 10 μs to 100 μs of thewaveform, and the third period comprises at least a portion of 100 μs to200 μs of the waveform, wherein the first period is defined by a peak ormaximum amplitude and the second and third periods are defined by aremainder amplitude less than the maximum amplitude. In this embodiment,the peak or maximum amplitude is in a range of 20 mA to 50 mA. In thisembodiment, in the second period, a decay of the remainder amplitude isdefined by a first negative slope having a first magnitude and, in thethird period, a decay of the remainder amplitude is defined by a secondnegative slope having a second magnitude, wherein the first magnitude isless than the second magnitude. In this embodiment, an average of thepeak or maximum amplitude and the remainder amplitude is in a range of10 mA to 30 mA.

In various embodiments, any two consecutive stimulation pulses, havingwaveforms described with reference to embodiments above and FIG. 61, areseparated by a predefined time interval. In some embodiments, thepredefined time interval is in a range of 1 minute to 10 minutes. Inother embodiments, the predefined time interval is randomized and is atleast 1 minute.

It should further be appreciated that, in contrast to certain prior artapproaches, the waveform is preferably a single waveform and not amultiplexed, integrated, or otherwise combined set of multiple waveformsin different frequency ranges, particularly waveforms greater than 500Hz.

In one embodiment, the EDP has a predefined voltage limit, for examplein a range of 40 to 60 volts or any increment therein. This voltagelimit has the effect of quickly degrading an initial 30 mA pulse down toa lower amperage, for example 18 mA.

In accordance with an aspect of the present specification, the user aswell as the remote patient care facility or personnel are able tocontrol and adjust the plurality of stimulation parameters through theHealth Management application and/or by the user via actuators 122 suchas buttons or switches of FIG. 1A. In some embodiments, the remotepatient care facility or personnel is authorized to control and adjustall stimulation parameters while the user is enabled to control andadjust a subset of the stimulation parameters with or withoutauthorization/approval of the remote patient care facility or personnel.For example, the user may be allowed to change the number of stimulationsessions per day from, for example, 2 sessions per day to 1 session perday; stimulation session duration from, for example, 30 minutes to 15minutes; and/or stimulation pulse amplitude from, for example, 20 mA to150 μA. In one embodiment, the maximum change is limited to a predefinedamount or multiple of the prior settings.

It should be noted that changing the pulse width is a less energyefficient approach as it requires the fixed voltage to be larger thantypically needed. Energy efficiency considerations involve varying boththe pulse width and pulse amplitude to find the minimum combination thatwill cause neural activation. In some embodiments, patients may usesensory feedback to modify stimulation or as a mechanism to choose. Forexample, in using a larger amplitude, the patient may experience moreirritation or a tingly sensation and can thus use the discomfort as ameans of modifying therapy. In some embodiments, battery life may alsodictate the choice of whether to increase pulse width, pulse amplitudeor both.

In a preferred embodiment, the user is able to increase the stimulationpulse amplitude from a minimal default amplitude setting of, say, 100 μAto a ‘sensory threshold’ corresponding to amplitude where the user canjust feel the stimulation. The user may then save the ‘sensorythreshold’ setting and continue stimulation at this setting. The sensoryperception varies from person to person and therefore in variousembodiments the ‘sensory threshold’ ranges from about 5 mA to 10 mA onthe lower side and from about 20 mA to 30 mA on the higher side.

In some embodiments, a stimulation protocol includes alternatingstimulation sessions between a first session having a low pulsefrequency, for example, less than 50 Hz, followed by a second sessionhaving a high pulse frequency, for example, greater than 50 Hz.

In still further embodiments, the user may be able to control and adjustthe subset of stimulation parameters within the standard settingsranges, such as those described above, or within a narrower band ofrange or constrained range within the standard settings ranges. Forexample, the user may be allowed to modify the stimulation pulse width,amplitude and frequency by no more than +/−50% from the original,default or standard setting. In another example, the user may be allowedto modify all stimulation parameters by +/−10% (from the original,default or standard setting) except for allowing the amplitude todecrease unbounded in order to address safety and/or comfort reasonsUser modification of the stimulation parameters beyond the constrainedrange may require authorization from the remote patient care facility orpersonnel. In some embodiments, the range within which the user is ableto control and adjust the subset of stimulation parameters is set by theremote patient care facility or personnel. Also, in some embodiments,the user may be allowed to control and adjust stimulation parameterswithin a first range at the onset of therapy, but as therapy progresses(for example, after 2 to 3 weeks) the user is allowed to control andadjust stimulation parameters within a second range wherein the secondrange is narrower, limited or constrained compared to the first range.

It should be appreciated that the type and number of stimulationparameters that the user is allowed to control and adjust can vary inmultiple embodiments.

In accordance with an aspect of the present specification, the HealthManagement software application provides a plurality of pre-configureddefault or standard stimulation protocols to drive therapy for aplurality of conditions such as obesity, over-weight, eating disorders,metabolic syndrome or appetite suppression and T2DM, as examples.

Example Stimulation Protocols for Treating Conditions of Obesity,Over-Weight, Eating Disorders, Metabolic Syndrome or AppetiteSuppression and/or T2DM

In various embodiments, a standard stimulation protocol, for stimulatingthe T6, C8 and/or T1 dermatome for treating conditions of obesity,over-weight, eating disorders, metabolic syndrome or for appetitesuppression and the T7 dermatome for treating T2DM, may comprise aplurality of pre-configured standard settings such as at least threesetting options, for example mild, optimal, intense. For example, anembodiment of a standard optimal stimulation protocol comprises two 30minute sessions a day, 30 to 45 minutes before lunch and right beforebed or after a specific time, say, after 8 or 9 pm, at an intensity thatdoesn't bother patient, but can still be felt by them, such as at afrequency of 20 Hz and at a ‘sensory threshold’ amplitude of 10 mA. Astandard mild stimulation protocol comprises one 20 minute session aday, 30 to 45 minutes before lunch or right before bed or after aspecific time, say, after 8 or 9 pm, at a frequency of 20 Hz and at a‘sensory threshold’ amplitude of 5 to 35 mA. A standard intensestimulation protocol comprises three 30 minute sessions a day, 30 to 45minutes before lunch, right before bed and also after a specific time,say, after 8 or 9 pm, at a frequency of 40 Hz and at a ‘sensorythreshold’ amplitude of 10 mA. In some embodiments, a latency effect isencountered with stimulation wherein the stimulation is provided for aspecific amount of time and the effect is not witnessed until a certainamount of time has passed and/or the effect remains for a certain amountof time post stimulation. For example, in one embodiment, ghrelinremains suppressed for at least several weeks post stimulation.

It should be noted that, in various embodiments, the stimulationparameters and protocols enable treatment of conditions of obesity,over-weight, eating disorders, metabolic syndrome or appetitesuppression and/or T2DM without causing painful, uncomfortable oruncontrollable sensations to the user (that is, without reaching apainful threshold of sensation).

In one preferred embodiment a standard or baseline stimulation scheme orprotocol (also referred to as ‘default operational mode’) is set at, forexample, 3 daily stimulation sessions of 30 minutes each having a pulseamplitude of 20 mA. Each of the three daily stimulation sessions isinitiated 30 to 60 minutes and preferably 45 minutes prior to mealtimes,such as, breakfast, lunch and dinner, for example. In variousembodiments, the remote patient care facility or personnel set times forthe meals that, in some embodiments, may be in accordance with a dietplan. Thus, the HMA application is pre-set at the standard or baselinestimulation protocol to begin stimulation in absence of any initialhealth related data of the user. As the therapy progresses, the HealthManagement application recommends and periodically adjusts the baselinestimulation protocol or pattern based on the user's health relatedinformation. In another preferred embodiment, the baseline stimulationscheme or protocol is set at 3 daily stimulation sessions of 15 minuteseach having a pulse amplitude of 20 mA timed pre-prandial and 60 minuteseach having a pulse amplitude of 20 mA timed post-prandial, that isimmediately prior to commencement and upon completion of each meal suchas breakfast, lunch and dinner. In other words, the baseline stimulationscheme or protocol comprises 3×1.25 hours=3.75 hours total (15 minutespre-prandial to each meal and 60 minutes post prandial). In someembodiments, the base line pulse amplitude ranges from 5 mA to 10 mA toenable total stimulation durations that are longer than 3.75 hours. Invarious embodiments, these post-prandial stimulation sessions aretriggered manually by the user. In some alternate embodiments, thepre-prandial and post-prandial stimulation sessions are automaticallytriggered based on pre-stored meal time schedule. In some alternateembodiments, the post-prandial stimulation sessions are automaticallytriggered with reference to a detection of an eating event by a swallowdetection device, such as the device 5605 of FIG. 56, or by the eatingmoment recognition method (FIG. 58) implemented by the HMA using aplurality of data (representing the user's food intake gestures)captured by an accelerometer, wherein the accelerometer is included in awrist-band or wristwatch, such as the band 2105 of FIG. 21A or thewristwatch 2106 of FIG. 21B.

It should be appreciated that, in some embodiments, the standard optimalstimulation protocol (out of the three options of mild, optimal andintense) is set at the baseline stimulation protocol which is thedefault protocol set for most users. In still alternate embodiments, thestandard baseline stimulation protocol is the only pre-configuredsetting available to users instead of multiple stimulation options, suchas the three options of mild, optimal and intense. However, the baselinestimulation protocol is programmable, adjustable or modifiable. That is,in various embodiments, the remote patient care facility or personnelcan modify the baseline stimulation parameters to a higher level ofstimulation, longer duration and/or more times daily.

It should be appreciated that the default or base stimulation protocolmay be set through a number of different mechanisms. First, a biomarkermay be used to define a threshold which, if met, would indicate a propera default or baseline stimulation setting. In one embodiment, thebiomarker may be pain level, heart rate values, skin impedance values,degree of pupil dilation, blood pressure values, salivary cortisolvalues, or EKG values. Pain level may be determined by a visual analogscale and having a patient either verbally state or input into acomputing device a level on a visual analog scale that equates to theamount of pain being experienced by the patient. Heart rate and bloodpressure may be determined from conventional heart rate monitors, whichmay be incorporated into a watch or patch, or blood pressure monitors.Pupil dilation may be measured visually or using a camera. EKG valuesmay be determined from conventional EKG devices. Skin impedance valuesmay be determined from impedance sensors incorporated into the EDP.

The biomarker may be used to determine when a patient is receiving asufficient amount of stimulation. For example, in one embodiment, if themeasured heart rate increases by at least 5%, but no more than 20%, overa period of five minutes after stimulation initiates, the providedstimulation is sufficient. If the measured heart rate does not increaseby at least 5%, then the provided stimulation is not sufficient. If themeasured heart rate increases by more than 20%, preferably 15% and morepreferably 10%, then the provided stimulation is too excessive.

For example, in one embodiment, if the measured pain level, using a VASscale, exceeds 5, but is less than 8, over a period of five minutesafter stimulation initiates, the provided stimulation is sufficient. Ifthe measured pain level does not exceed 5, then the provided stimulationis not sufficient. If the measured pain level exceeds 8, then theprovided stimulation is too excessive.

For example, in one embodiment, if the measured blood pressure increasesby at least 5%, but no more than 20%, over a period of five minutesafter stimulation initiates, the provided stimulation is sufficient. Ifthe measured blood pressure does not increase by at least 5%, then theprovided stimulation is not sufficient. If the measured blood pressureincreases by more than 20%, preferably 15% and more preferably 10%, thenthe provided stimulation is too excessive.

For example, in one embodiment, if the measured skin impedance increasesby at least 5%, but no more than 20%, over a period of five minutesafter stimulation initiates, the provided stimulation is sufficient. Ifthe measured skin impedance does not increase by at least 5%, then theprovided stimulation is not sufficient. If the measured skin impedanceincreases by more than 20%, preferably 15% and more preferably 10%, thenthe provided stimulation is too excessive.

For example, in one embodiment, if the measured degree of pupil dilationincreases by at least 5%, but no more than 20%, over a period of fiveminutes after stimulation initiates, the provided stimulation issufficient. If the degree of pupil dilation does not increase by atleast 5%, then the provided stimulation is not sufficient. If the degreeof pupil dilation increases by more than 20%, preferably 15% and morepreferably 10%, then the provided stimulation is too excessive.

For example, in one embodiment, if the measured EKG values increase byat least 5%, but no more than 20%, over a period of five minutes afterstimulation initiates, the provided stimulation is sufficient. If theEKG values do not increase by at least 5%, then the provided stimulationis not sufficient. If the EKG values increase by more than 20%,preferably 15% and more preferably 10%, then the provided stimulation istoo excessive.

For example, in one embodiment, if the measured salivary cortisol valuesincrease by at least 5%, but no more than 20%, over a period of fiveminutes after stimulation initiates, the provided stimulation issufficient. If the salivary cortisol values do not increase by at least5%, then the provided stimulation is not sufficient. If the salivarycortisol values increase by more than 20%, preferably 15% and morepreferably 10%, then the provided stimulation is too excessive.

Operationally, a patient would first be subjected to a stimulationhaving a low range of stimulation values, such as a pulse amplitude of20 mA, a pulse width of 120 μsec, and a pulse frequency of 30 Hz. If oneor more of the aforementioned biomarkers do not achieve the requisitethreshold, the patient would be subjected to a stimulation having amedium range of stimulation values, such as a pulse amplitude of 30 mA,a pulse width of 120 μsec, and a pulse frequency of 30 Hz. If one ormore of the aforementioned biomarkers do not achieve the requisitethreshold, the patient would be subjected to a stimulation having a highrange of stimulation values, such as a pulse amplitude of 40 mA, a pulsewidth of 120 μsec, and a pulse frequency of 30 Hz.

In another embodiment, the process could be reversed. Operationally, apatient would first be subjected to a stimulation having a high range ofstimulation values, such as a pulse amplitude of 40 mA, a pulse width of120 μsec, and a pulse frequency of 30 Hz. If one or more of theaforementioned biomarkers exceeds the requisite threshold, the patientwould be subjected to a stimulation having a medium range of stimulationvalues, such as a pulse amplitude of 30 mA, a pulse width of 120 μsec,and a pulse frequency of 30 Hz. If one or more of the aforementionedbiomarkers still exceed the requisite threshold, the patient would besubjected to a stimulation having a low range of stimulation values,such as a pulse amplitude of 20 mA, a pulse width of 120 μsec, and apulse frequency of 30 Hz.

Some embodiments additionally comprise a custom setting option thatallows the user to adjust or set the subset of stimulation parameters,which he is allowed to control, within constrained ranges. It should beappreciated that the number of pre-configured settings (such as mild,optimal, intense) may vary across various embodiments. Also, thestimulation protocol, with its mild, optimal and intense configurations,is only exemplary and may vary across various embodiments and fortargeting specific conditions such as only appetite suppression or T2DM.For example, a stimulation protocol directed towards ghrelin modulation,and therefore appetite modulation, may include a stimulation pulse widthof 200 μsec, pulse amplitude corresponding to the user's ‘sensorythreshold’ such as 20 mA, pulse frequency of 20 Hz, stimulation sessionduration of 30 minutes and one session per day for 4 weeks. Anotherexample stimulation protocol directed towards appetite suppression mayinclude a 15 minutes stimulation session, using a current frequency of 6Hz of 0.1 milliseconds (ms) duration starting at intensities of 1 to 20milliampere (mA) until the intensity reaches the user's ‘sensorythreshold’.

In accordance with an aspect of the present specification, the HealthManagement application recommends and periodically adjusts thestimulation protocols or patterns based on the user's health relatedinformation, such as the user's hunger profile, standard eating andmeals profile, actual eating and meals profile, energy balance, weighttrends, glucose data and stimulation induced nausea, dyspepsia,habituation events. For example, if the user's energy balance ispositive by about 5% beyond a pre-defined positive energy balancethreshold at a certain calories consumption schedule per day, asdictated by the user's standard regular eating and meals profile, andthe user is also found to be over-weight or obese, the Health Managementapplication may suggest commencing with the optimal stimulation protocolfor two weeks along with an activities regiment comprising, for example,daily or weekly goals of walking, exercising, running, swimming directedtowards increasing the user's calories expenditure. The HealthManagement application monitors compliance of the user to therecommended optimal stimulation protocol and the activities regimenthroughout the two weeks. The user's resulting energy balance andcompliance profile is recorded and displayed to the user in the form ofcharts, graphs, tables or any other visual format as would beadvantageously evident to persons of ordinary skill in the art. At thecommencement or throughout the duration of the therapy, the HealthManagement application may also recommend a standard or customizeddietary plan to the user as part of a holistic approach to improvingeffectiveness of the stimulation therapy. For example, Table 3 shows a1200 Kcal/day customized diet plan (from a plurality of such diet planspre-stored within the Health Management application) recommended by theHealth Management application:

TABLE 3 Mean values of carbohydrates 51%; proteins 23%; fats 26% MealContents Breakfast Skimmed milk 200 cc or 2 natural skimmed yoghourtsBread 50 g or 2 toasts of “biscotti” type bread Mid-morning Fruit (onepiece, 100 g of apple, pear, orange, melon or kiwi) Meal and dinner Maincourse to choose from: Vegetables 200 g: spinach, chard, eggplant,watercress, endive, lettuce, cauliflower, mushroom, leek, asparagus,escarole, cabbage, cucumber, peppers, tomatoes, alternating cooked or ina salad, or 150 g of green beans, beet, carrot, artichoke or Brusselssprouts Vegetable soup Skimmed broth (free consumption) Andalusiangazpacho, provided it is prepare without bread and a small amount ofoil, remembering not to exceed the ration of oil for the whole dayPasta, semolina, rice or tapioca soup (15 g dry) Second course to choosefrom: White fish 120 g Chicken, turkey, rabbit, veal meat 100 g Eggs,one unit Tomatoes and lettuce salad (or any other raw vegetable) 150 gonly once a day Dessert, to choose from: Fruit (one piece, 100 g ofapple, pear, orange, kiwi, melon or 200 g of watermelon) Bread 25 gAfternoon snack 200 cc of skimmed milk, just milk or with coffee or teaOil for all day 30 cc (2 soup spoons)

If the user's energy balance and/or weight trend shows improvement, forexample the energy balance reduces up to or below the positive energybalance threshold and/or the rate of weight reduction is withinpre-defined acceptable limits, the Health Management application mayrecommend the user to shift to the mild stimulation protocol for thenext two weeks. For example, if the rate of weight reduction or lossexceeds or is above a pre-defined threshold, for example X % over Y %,the Health Management application may recommend or automatically titratetherapy from a current optimal stimulation protocol to the mildstimulation protocol. On the other hand, if the user's energy balanceand/or weight trend deteriorates or remains same as at the commencementof the stimulation therapy due the user's non-compliance to theactivities regimen (as a result of which the user is not burning arequisite amount of calories), for example if the user's energy balanceis found to be positive by about M %, wherein M %>L % and/or the rate ofweight reduction is below the pre-defined acceptable limits or there isno significant weight reduction, the Health Management application mayrecommend the user to shift to the intense stimulation protocol for thenext two weeks.

In accordance with aspects of the present specification, the HealthManagement Application continuously monitors and analyzes the user'splurality of health related information or data to identify emerginghealth trends and consequently, based on identified health trends orpatterns, automatically (as opposed to manually by the user and/or bythe TPM) determines and generates one or more interventions inreal-time, within a predefined period of time, time-frame or time-windowof identifying a health trend and/or at a future time window at whichthe identified health trend or pattern is expected to occur.

In embodiments, the HMA is programmed to identify health trends withreference to any one or a combination of any two or more of the user'splurality of health related information, such as the user's hungerprofile, standard eating and meals profile, actual eating and mealsprofile (including caloric intake), energy balance, weight data andtrends, glucose data, will power levels, daily or periodic scoresrelated to hunger, appetite, and well-being (‘diary’ inputs), exerciseor caloric expenditure, daily or periodic composite scores, stimulationinduced nausea, dyspepsia and habituation events. The user's pluralityof health related information or data also includes physiological datafrom a separate device, with physiological sensors, configured to beworn on the human body, such as around the wrist.

Appetite data, which is indicative of a degree of appetite beingexperienced by the patient, is stored in a database in association witha time of day and a calendar day. The system accesses the database toobtain the appetite data and process it to generate appetite graphs,tables, charts, or other visual displays. The system further accessesthe database to obtain the appetite data and process it to develop anappetite pattern that determines, for future time windows, a likelyappetite level of the patient. The system saves the appetite pattern,comprising a plurality of appetite levels for particular time windows ona given calendar day, and further uses that appetite pattern to triggerinterventions based on such predicted appetite levels. An exemplarydatabase therefore comprises an actual historical log of appetitelevels, saved in association with a time of day, a time window, and/or acalendar day and a predicted future pattern of appetite levelsassociated with a time of day, a time window, and/or a calendar day.

FIG. 70 is a flow chart illustrating a plurality of steps involved in anembodiment of a method of using an EDP device to automatically generateone or more interventions based on identified health trends of a user.At step 7002, the user obtains an electro-dermal patch (EDP) device andpairs the EDP device with a companion device (running the HMA of thepresent specification), such as a smartphone, and a separate device, forexample, a device, with physiological sensors, configured to be worn onthe human body, such as around the wrist, in order to monitor, acquire,record, and/or transmit the physiological data. In some embodiments,pairing with the separate device can be done anytime within a treatmentcycle. At step 7004, the device is set into a default operational mode.In some embodiments, the default operational mode includes the followingstimulation parameters: a pulse width in a range of 10 μsec to 10 msec,a pulse amplitude in a range of 100 μA to 100 mA, and a pulse frequencyin a range of 1 Hz and 100 Hz. In some embodiments, the defaultoperational mode is set, for most patients, at 3 daily stimulationsessions of 30 minutes each to be initiated 30 to 60 minutes andpreferably 45 minutes prior to or following an end of mealtimes, suchas, breakfast, lunch and dinner, for example. In some embodiments, thedefault operational mode includes the stimulation parameters andparameter ranges listed with respect to FIG. 27C and includes dailystimulation. The EDP device is positioned on the user's body at step7006 for use.

At step 7008, the companion device, executing the HMA, prompts for,where needed, acquires and stores the plurality of health relatedinformation or data over a first predefined period of time, immediatelyfollowing wearing or use of the EDP for the first time, and a secondperiod of time subsequent to the first predefined period of time. Inembodiments, the first predefined period of time is referred to as the‘learning period’ during which the HMA attempts to acquire enough datapoints related to one or more of the health related information or datathat is deemed to be sufficient to identify one or more health trends orpatterns. The ‘learning period’ is the time-frame immediately followinguse of the EDP by the user for the first time. In various embodiments,the ‘learning period’ is in a range of one day to one month. The secondperiod of time following the ‘learning period’ is typically continuous(as opposed to be being predefined and time-bound as the ‘learningperiod’) till an end of a therapy and/or attainment of one or moreobjectives of the therapy.

As discussed earlier in the specification, the HMA is programmed toperiodically prompt the user for providing his ‘daily diary’ inputs orany other health related information for which user's explicit or manualinput may be necessary such as, for example, glucose data in scenarioswhere the glucose data is determined by the user using a third-partyglucometer that may not be in data communication with the companiondevice. In accordance with aspects of the present specification, the HMAimplements a notification protocol during the ‘learning period’ thattriggers the HMA to generate notification or prompts for the user, toinput or provide relevant health related information such as appetite orhunger data, at predefined time intervals. In embodiments, the HMAprioritizes assessment of the user's hunger or appetite profile, duringthe ‘learning period’, to subsequently identify related trends orpatterns.

In embodiments, the HMA prompts the user to input data indicative of theuser's degree of appetite or hunger (and/or other ‘daily diary’parameters such as exercise and well-being) via a microphone or adisplay of the client or companion device. In various embodiments, theuser is prompted at associated predefined times and his inputs aresubsequently received and time-stamped using any one of the following:visual prompts comprising, generating on a touch-enabled display of thecompanion device, a light bar VAS, VAS configured as a questionnaire,numbers, color spectrum (as illustrated in FIG. 76) or a plurality oficons, emojis or emoticons and enabling the user to provide finger-basedinputs (identifying a value on the VAS or identifying an emoji that isvisually representative of the user's degree of appetite) of his degreeor intensity of appetite/hunger or haptic inputs such as, for example,specific number of finger-tapping of the display screen by the userbeing indicative of a degree of appetite or hunger (for example, fivefinger-taps on the display screen would mean an appetite or hunger scoreof 5 on a scale of 10), by shaking motion of the companion devicewherein an extent of said moving is indicative of the patient's degreeof appetite (for example, seven shakes of the companion device wouldmean an appetite or hunger score of 7 on a scale of 10) or throughpre-defined physical body movements, such as (for example) hapticmotions of the wrist or hand, when the user is wearing a wristwatch orwristband (that includes an accelerometer or inclinometer to detect,capture and acquire the user's haptic motions); vibratory prompts(through the companion device and/or the EDP device) wherein the usercan subsequently provide his inputs through any of the haptic motions asdiscussed above or by actuating buttons on the EDP device; auditoryprompts wherein the HMA in communication with the IPA system, thecompanion device or the EDP device enables delivering voice basedprompts to the user and receiving voice based user inputs through theIPA system, the companion device or the EDP device; by actuating abutton on the EDP device itself or on a remote toggle switch configuredto be worn around the user's neck or placed on his wrist in the form ofa wristwatch or wristband; or by activating a light source (such as oneor more LEDs) on the EDP device. Thus, the prompt triggered by the HMAis in a form of at least one of an audio message, video message, textmessage, and graphical message.

In some embodiments, the user is auditorily prompted an appetite scaleand the user's time stamped inputs are received through at least one ofa finger-based input, haptic input, or vocal input.

In embodiments, the notification protocol triggers the prompts at afirst rate or frequency during the ‘learning period’ (first period oftime) and at a second rate or frequency during the second period of time(that is, after the ‘learning period’) wherein the second rate is lessthan the first rate. The goal is to intensively barrage the user withinput requests for appetite/hunger to establish a pattern during thelearning period—that is, gain enough data to generate customized orpersonalized interventions and therapy. In one embodiment, an intervalbetween notifications is at least 1 hour and the first rate ofnotifications is more than 1 time a day and less than 24 times a day. Insome embodiments, the frequency of notifications may decrease at an endof the ‘learning period’ or when the HMA establishes a trend or pattern.In alternate embodiments, the frequency of notifications may remainunchanged.

Optionally, in embodiments, the notification option and the notificationprotocol may or may not be activated by the user on his companiondevice. In embodiments, the notification option and the notificationprotocol for the ‘learning period’ is active by default and may bedeactivated by the user. In some embodiments, the user is allowed tocontrol/modify the first rate or frequency of notifications—with aconstraint that the user cannot decrease the frequency of notificationsto less than one time per day.

At step 7010, the companion device, executing the HMA, continuously orperiodically analyzes the user's plurality of health related informationor data, over a predefined period of time, to identify one or morehealth patterns or trends. In some embodiments, a health trend may bederived by creating or generating a topographical map descriptive of theuser's one or more health related information or data and determiningtrends from the map.

At step 7012, the HMA determines if a health trend or pattern exists oris confirmed. If a health trend exists or is confirmed, then at step7014, the HMA prospectively automatically generates and provides to theuser at least one of a plurality of types of interventions based on aprediction of what appetite level a patient will likely have in a givenfuture time window. More specifically, once a pattern has beendetermined, the HMA has a degree of confidence that in a future timewindow, the patient's appetite will be less than, equal to, or greaterthan a predefined appetite threshold. Based upon such a determination,an intervention may be triggered, where the level and type ofintervention is based on the degree to which the patient's appetite isless than, equal to, or greater than the predefined threshold. Suchinterventions include:

-   -   Coaching based intervention—providing online coaching or advice        (including graphics, audio, video and/or text messages) on how        to manage appetite (for example). In some embodiments, the        coaching based intervention generates at least one of a visual        display or auditory communication indicative of advice related        to the patient's degree of appetite, wherein the advice provides        guidance regarding the user's administration of medicine,        selection of food, timing of meals, eating of food, abstaining        from food, engaging in exercise, selection of a diet plan, or        degree of compliance with a diet. Such a coaching-based        intervention would be triggered if the patient's appetite is        predicted to be greater than the predefined threshold value in a        given time window. Alternatively, such a coaching based        intervention would be triggered in real-time relative to the        acquisition of the patient's appetite data, if such appetite        data was above a predefined threshold.    -   Social network based intervention—allowing pre-recorded or        real-time graphics, audio, video and/or text messages to be        communicated to the user from members of the user's affinity        group or social network. In embodiments, the social network        based intervention enables the HMA to connect to a social        network (of which the user is a member) and receive from the        social network at least one of visual displays of advice related        to the user's degree of appetite, auditory communications of        advice related to the user's degree of appetite, automated        messages, pre-recorded messages from connected individuals on        the social network, and real-time messages from connected        individuals on the social network. In embodiments, the advice        provides guidance regarding the user's administration of        medicine, selection of food, timing of meals, eating of food,        abstaining from food, engaging in exercise, selection of a diet        plan, or degree of compliance with a diet. Such a social        networking-based intervention would be triggered if the        patient's appetite is predicted to be greater than the        predefined threshold value in a given time window.        Alternatively, such a social networking-based intervention would        be triggered in real-time relative to the acquisition of the        patient's appetite data, if such appetite data was above a        predefined threshold.    -   Rescue session based intervention—providing at least one rescue        session to the user at a time of day. Such a rescue        session-based intervention would be triggered if the patient's        appetite is predicted to be greater than the predefined        threshold value in a given time window. Alternatively, such a        rescue session-based intervention would be triggered in        real-time relative to the acquisition of the patient's appetite        data, if such appetite data was above a predefined threshold.    -   Stimulation titration based intervention—modifying, adjusting or        titrating the default stimulation parameters and protocols.        Specifically, the system modifies at least one of a timing,        intensity, pulse width, pulse amplitude, and pulse frequency of        the electrical stimulation. In embodiments, the stimulation        titration based intervention also includes determining at least        one of a plurality of times of day when electrical stimulation        is needed, a plurality of times of day when electrical        stimulation is not needed, and a change to one or more scheduled        electrical stimulations. In some embodiments, the health trend        may be positive leading to an automatic moderation or        down-modulation of the stimulation parameters, protocols or        patterns. In some embodiments, the health trend may be negative        leading to an automatic immoderation or up-modulation of the        stimulation parameters, protocols or patterns. A stimulation        increased titration-based intervention would be triggered if the        patient's appetite is predicted to be greater than the        predefined threshold value in a given time window. A stimulation        decreased titration-based intervention would be triggered if the        patient's appetite is predicted to be less than the predefined        threshold value in a given time window. Alternatively, such a        stimulation increased titration-based intervention would be        triggered in real-time relative to the acquisition of the        patient's appetite data, if such appetite data was above a        predefined threshold. Alternatively, such a stimulation        decreased titration-based intervention would be triggered in        real-time relative to the acquisition of the patient's appetite        data, if such appetite data was below a predefined threshold.    -   Data display based intervention—in some embodiments, causing an        appetite pattern or the user's historical degree of appetite to        be displayed on the companion or client device, wherein the        appetite pattern is in a form of a heat map or graph having a        time of day on a first axis, a calendar day on a second axis,        and an icon representing a degree of the user' appetite plotted        on the graph in relation to the time of day and calendar day. At        least one of a size, shape, color, or pattern of the icon is        indicative of the patient's degree of appetite or an amount of        change in the user's degree of appetite over a plurality of        days. It should be appreciated that the user's appetite pattern        or historical degree of appetite may be displayed in a form of        at least one of a heat map, topographical map, chart, table, and        graph. Such a data display-based intervention would be triggered        if the patient's appetite is predicted to be greater than the        predefined threshold value in a given time window.        Alternatively, such a data display-based intervention would be        triggered in real-time relative to the acquisition of the        patient's appetite data, if such appetite data was above a        predefined threshold.

In some embodiments, the intervention is directed towards displayingdata indicative of a degree of the user's appetite superimposed on dataindicative of at least one of: a plurality of electrical stimulationsapplied to the user automatically, a plurality of electricalstimulations requested by, and applied to, the user, exercise performedby the user, calories consumed by the user, meals consumed by the user,and medication taken by the user.

In some embodiments, the superimposed data is represented by a firsticon and a second icon plotted on a chart with a calendar day on oneaxis and a time of day on a second axis and wherein at least one of acolor and a size of the first icon is indicative of the user's degree ofappetite and wherein at least one of a color and size of the second iconis indicative of at least one of an intensity of the plurality ofelectrical stimulations applied to the user automatically, an intensityof the plurality of electrical stimulations requested by, and appliedto, the user, an amount of exercise performed by the user, an amount ofcalories consumed by the user, a timing of the meals, and an amount ofmedication taken by the user.

In other embodiments, the superimposed data is represented by a firsticon and a second icon plotted on a chart with a calendar day on oneaxis and a time of day on a second axis and wherein at least one of acolor and a size of the first icon is indicative of a change in theuser's degree of appetite and wherein at least one of a color and sizeof the second icon is indicative of a change in at least one of anintensity of the plurality of electrical stimulations applied to theuser automatically, an intensity of the plurality of electricalstimulations requested by, and applied to, the user, an amount ofexercise performed by the user, an amount of calories consumed by theuser, a timing of the meals, and an amount of medication taken by theuser.

In accordance with some embodiments, the intervention is directedtowards displaying data of the user's historical degree of appetite onthe companion device, wherein the data is represented by icons plottedon a first heat map with calendar days on one axis and a time of day ona second axis and wherein a color of the icons is indicative of thepatient's degree of appetite and where the data is represented by iconsplotted on a second heat map with calendar days of the month on one axisand a time of day on a second axis and wherein a color of the icons isindicative of the user's degree of appetite, wherein the first heat maprepresents data taken over a first time period and a second heat maprepresents data taken over a second time period, and wherein adifference in the patient's degree of appetite between the first heatmap and second heat map is represented by a value.

FIG. 72A shows a first heat map 7205 plotted with a first set of iconsor dots 7215 representing a user's appetite data over a first timeperiod, such as a first week. The first heat map 7205 has calendar days7210 on the x-axis and time of day 7212 on the y-axis. FIG. 72B shows asecond heat map 7220 plotted with a second set of icons or dots 7225representing the user's appetite data over a second time period, such asa second week immediately following the first week. The second heat map7220 also has calendar days 7210 on the x-axis and time of day 7212 onthe y-axis. A color of the first and second set of icons or dots 7215,7225 represents the user's degree of appetite. For example, in someembodiments, the color of the icons or dots may range from white, gray,black, green, yellow, orange to red wherein white representing a lowestintensity or degree of appetite, red representing a highest degree ofappetite and other colors, between white and red, representingprogressive degrees of appetite. When the first and second heat maps7205, 7220 are displayed to the user they indicate a change (increase ordecrease) in the user's appetite between the first and second timeperiods. Thus, based on one or more interventions the user's heat mapmay evolve from the first map 7205 to the second map 7220 (ofdiminishing red dots and expanding green dots) indicating an efficacy ofthe overall treatment provided by the EDP.

It should be appreciated that appetite or hunger data represented onheat maps, such as the map 7205 or 7220, is actionable becauseinterventions, such as titration of stimulation therapy, can bedetermined, timed and prescribed depending on appetite/hunger intensityand time of day and day of month. In some embodiments, the stimulationtherapy can be scaled proportionately to the numerical appetite orhunger inputs. For example, if the user enters an appetite or hungerscore of 8 (on a hunger scale of 0 to 10) it may result into animmediate intervention in the form of a rescue stimulation session, forexample, along with automated coaching advice and/or peer support (inthe form of messages from individuals who are members of the affinitygroup of which the user is also a member). In another example, if theuser's weekly or monthly heat map reveals hotspots (high intensityappetite or hunger data) concentrated around certain times of the day,the stimulation therapy can be adjusted accordingly and targeted atvulnerable times of day. In embodiments, the interventions aim to focuson shifting the user's orange and red hotspots at certain times of dayin a week to green dots at the same times of day in subsequent weeks.

It should be appreciated that, in some embodiments, the color of theicons or dots 7215, 7225 directly represents a color on a color spectrumbased VAS (such as the VAS 7600 of FIG. 76) that is used to receive theuser's inputs regarding an intensity of his appetite or hunger.

In other embodiments, the heat maps can also be used for researchpurposes. For example, to compare the efficacy of different weight losstreatments: sleeve gastrectomy vs lap band, low fat diet vs high proteindiet, and to anticipate weight regain by monitoring post-surgery (orpost weight loss) patients so as to observe their hunger related stateand look for increases in hunger scores. In still another example, theremay also be benefits for diabetic patients in titrating their medicationin advance of anticipated hotspots. Using heat maps, the HMA canestablish a correlation between hunger hotspots and glucometer scores.Since, hunger/appetite is a precursor to eating so being able toquantify and time appetite/hunger allows the patient or therapist toanticipate and act preemptively.

In accordance with still other embodiments, the intervention is directedtowards receiving a weight trend of the user and an appetite pattern anddetermines a composite score of the user, wherein the composite score isa function of the user's historical degrees of appetite and weighttrend. In one embodiment, the intervention causes the composite score tobe displayed on the client device. In another embodiment, theintervention causes the client device to transmit the composite score toan online affinity or social network group, wherein the user is a memberof the online affinity or social network group. In one embodiment, theintervention causes the daily or weekly composite scores to be displayedas icons or dots on heat maps.

In accordance with yet another embodiment, the intervention is directedtowards plotting and displaying a composite score as icons or dots onheat maps, such as the map 7205 or 7220. In such embodiments, thecomposite score is daily or weekly appetite/hunger average or total.

It should be appreciated that the HMA automatically generates andprovides at least one of the plurality of types of interventions basedon at least the identified health trend or pattern—without any manualintervention from the user and/or a TPM. It should also be appreciatedthat at least one of the plurality of types of interventions isgenerated and provided to the user in any one of: in real-time withreference to identification of a health trend or pattern; within apredefined time-window such as within 72 hours, preferably within 24hours, preferably within 12 hours, preferably within 2 hours ofdetermining the health trend; or at a future time window at which thehealth trend is expected to occur or recur. The determination of ahealth trend, and more specifically an appetite pattern, is based onobtaining a sufficient amount of data, within a predefined range, for agiven time window. In particular, the system analyzes acquired appetitedata, each data element having a time stamp associated therewith, todetermine a) how many data points are within a given time window and b)whether the data is clustered around a particular value or toodistributed across a range of values to constitute a pattern. In oneembodiment, data is considered to be sufficiently clustered if amajority of data elements are within a predefined deviation from anaverage appetite value in a given time window. In one embodiment, datais considered to be sufficiently clustered if a majority of dataelements are outside a predefined deviation from an average appetitevalue in a given time window. A time window represents a range of timein a given day, such as from 11 am to 1 pm or 5 pm to 8 pm. In oneembodiment, preferably the time windows are no less than 1 hour and nomore than 6 hours.

In a first non-limiting example of steps 7012 and 7014, the HMAmonitoring or tracking the plurality of health related information ordata of the user may determine that the user's hunger level is above apredefined threshold level for ‘N’, say 3, number of consecutiveoccurrences, events, times or days—such as for ‘N’ consecutive mealevents or for one or more meal events spread over ‘N’ consecutive days.Therefore, the HMA may flag the repeat consecutive occurrences of suchhigh hunger levels as being indicative of a health trend. Consequently,the HMA automatically generates and provides at least one of theplurality of types of interventions for the corresponding future timewindows within which the pattern occurs.

In a second non-limiting example of steps 7012 and 7014, the HMAmonitoring or tracking the plurality of health related information ordata of the user may determine that the user's appetite level is above apredefined threshold at a specific times of day, say at lunch time, forat least ‘W’ days, say 2 days, in a row. Additionally, the user'swell-being level may be found to be at or above a predefined thresholdlevel (representative of stagnant sub-optimal or deterioratingwell-being) for the specific times of day and for at least ‘W’ days in arow. Based on the repeat consecutive occurrences of high appetite levelsas well as stagnant sub-optimal or deteriorating well-being, the HMA mayconclude that a health trend exists and, based on that, mayautomatically generate and provide at least one of the plurality oftypes of interventions for the corresponding future time windows withinwhich the pattern occurs.

In a third non-limiting example of steps 7012 and 7014, the HMAmonitoring or tracking the plurality of health related information ordata of the user may determine that the user's weight loss is below atarget range for ‘Z’ days, say 5 days, in a row. At the same time, theuser's appetite level is found to be slightly above a predefinedthreshold level and the user's well-being level is also found to be ator above a predefined threshold level (representative of stagnantsub-optimal or deteriorating well-being) for ‘Z’ days consecutively. Asa result, the HMA may conclude that a health trend exists and, based onthat, may automatically generate and provide at least one of theplurality of types of interventions for the corresponding future timewindows within which the pattern occurs.

In a fourth non-limiting example of steps 7012 and 7014, the HMAmonitoring or tracking the plurality of health related information ordata of the user may determine that the user reports ‘T’, e.g. 3, ormore entries of hunger levels above a predefined threshold level withina same or similar predefined time-frame or time-window on ‘V’ differentdays, where the ‘V’ different days are at least 3 and where each of thedays are separated by 1 to 2 days. Suppose the user reports hunger abovea threshold level within a time-window ranging from ±15 minutes to ±3hours of a time, say 6:45 am (or any other time, such as breakfast,lunch or dinner). In other words, the user reports hunger above athreshold level at 6:45 am, 7 am and 6:30 am on ‘V’, e.g. 3, respectivedifferent days. Such repeat occurrence of high hunger level within thesame time-window is determined as a potential health trend.Consequently, the HMA may automatically generate and provide at leastone of the plurality of types of interventions for the correspondingfuture time windows within which the pattern occurs. It should beappreciated, that if the high hunger level events are sporadic (forexample, the user reports hunger above a threshold level at 6:45 am, 2pm and 9 pm), that is not within a same or similar predefined time-frameor time-window, these are not recognized as patterns or health trends bythe HMA.

In a fifth non-limiting example of steps 7012 and 7014, the HMAmonitoring or tracking the plurality of health related information ordata of the user may determine that the user's weight loss target over aperiod of targeted time is not being met. Let us say that the HMAdetermines that the user has not lost X pounds of weight by week Y(required to achieve or be on track for achieving a weight loss goalover a stipulated period of time) and may conclude this to be a healthtrend that would lead to the user missing his weight loss goal. Based onthis determination, the HMA may automatically generate and provide atleast one of the plurality of types of interventions for thecorresponding future time windows within which the pattern occurs.

In a sixth non-limiting example of steps 7012 and 7014, the HMAmonitoring or tracking the plurality of health related information ordata of the user may validate the user's weight loss against a targetlinearly sloping weight trend or graph 7105 of FIG. 71. As shown in FIG.71, the user's goal or target is to reduce his first weight 7110 to asecond weight 7115 within a period of ‘q’ weeks 7120, wherein the secondweight 7115 is less than the first weight 7110. Thus, the user's weighttrend or graph 7105 is assumed to be downward sloping linearly over the‘q’ weeks 7120. Now, if at any point in time, say at the end of ‘r’weeks 7125 (‘r’ weeks is less than ‘q’ weeks) the user's weight may bew₁ 7130 that may lie above the required weight trend or graph 7105 atthe end of the ‘r’ weeks 7125. In other words, the user isunder-achieving his target weight loss. In such a situation, suppose theHMA determines a health trend related to hunger levels above apredefined threshold for ‘N’ consecutive days. At the same time, the HMAalso determines a health trend related to well-being levels being at orabove a predefined threshold (representative of stagnant sub-optimal ordeteriorating well-being) for ‘N’ consecutive days. Since the user'sweight w₁ 7130 lies above the required weight trend or graph 7105, theHMA may de-emphasize the well-being related health trend and emphasizeor attach a higher weight or consideration to the hunger related healthtrend. Based on such a determination, the HMA may automatically generateand provide at least one of the plurality of types of interventions forthe corresponding future time windows within which the pattern occurs.

However, if at any point in time, say at the end of ‘s’ weeks 7135 (‘s’weeks is less than ‘q’ weeks), the user's weight may be w₂ 7140 that maylie below the required weight trend or graph 7105 with reference to theend of ‘s’ weeks 7135. In other words, the user is over-achieving histarget weight loss. In such a situation, suppose the HMA determines ahealth trend related to hunger levels above a predefined threshold for‘N’ consecutive days. At the same time, the HMA also determines a healthtrend related to well-being levels being at or above a predefinedthreshold (representative of stagnant sub-optimal or deterioratingwell-being) for ‘N’ consecutive days. Since the user's weight w₂ 7140lies below the required weight trend or graph 7105, the HMA mayemphasize the well-being related health trend and de-emphasize or attacha lower weight or consideration to the hunger related health trend.Based on such a determination, the HMA may automatically generate andprovide at least one of the plurality of types of interventions. Inembodiments, the HMA may evaluate the user's weight to lie within acertain predefined range or band of the required weight trend or graph7105. A deviation of the user's weight above or below the predefinedband related to the weight graph 7105 is then used to weigh hungertrends vis-à-vis well-being trends to titrate stimulation.

In a seventh non-limiting example of steps 7012 and 7014, the HMAcompares the user's most recent set of data (first set of appetite data)indicative of his degree of appetite in relation to historical data(second set of appetite data) indicative of the user's previous degreeof appetite to determine to what extent the user's degree of appetitehas changed (increased or decreased) over a predefined period for thesame time of day. In embodiments, the HMA also generates a valueindicative of the determined degree of change of appetite. Subsequently,the HMA determines and automatically generates at least one of theplurality of types of interventions based on the comparison of the firstand second sets of appetite data.

In various embodiments, the type of intervention automatically generatedfor the user and/or a timing of providing the type of intervention tothe user—depends on the amount of change (increase or decrease) of theuser's most recent appetite data with respect to his historical appetitedata over a predefined period for the same time of day. In someembodiments, if the amount of change is less than a predefined thresholdvalue then a first type of intervention is automatically generated ortriggered and delivered to the user while if the amount of change ismore than the predefined threshold value then a second type ofintervention is automatically generated or triggered and delivered tothe user.

In an eighth non-limiting example of steps 7012 and 7014, the HMAdetermines an appetite pattern of the user based upon the inputtedappetite data by determining a time window associated with each of theinputted appetite data and, for each time window, determining at leastone of: if value ranges of all inputted appetite data associated withthe time window are or, alternatively, are not within a predefined rangearound a value to constitute a pattern; and if a number of individualinputted appetite data values associated with the time window aresufficiently large or alternatively too low to constitute a pattern. Inembodiments, the time window is in a range of 1 to 3 hours.Subsequently, the HMA determines and automatically generates at leastone of the plurality of types of interventions if the value ranges ofthe inputted appetite data associated with the time window constitute apattern.

In a ninth non-limiting example of steps 7012 and 7014, the HMA isconfigured to determine at least one of the following: prospectivelypredict the user's degree of appetite based upon an analysis ofhistorical appetite data in relation to specific times of day;prospectively identify periods in which the patient's degree of appetitewill exceed a threshold value based upon an analysis of historicalappetite data in relation to specific times of day, wherein the periodscorrespond to particular times of day; and determine if the user'sdegree of appetite is expected to be greater than or less than athreshold value at a future time window.

Subsequently, the HMA determines and automatically generates at leastone of the plurality of types of interventions in or before the futuretime window. For example, if the user's degree of appetite is expectedto be less than the threshold value at the future time window, then theHMA does not generate any intervention during the future time window.However, if the user's degree of appetite is expected to be greater thanthe threshold value at the future time window, the HMA generates atleast one of the plurality of types interventions during the future timewindow. In various embodiments, the HMA is configured to perform atleast one of the following tasks based on a prospective prediction ofthe patient's degree of appetite: 1) modify parameters for a pluralityof scheduled electrical stimulations, 2) add additional electricalstimulations, 3) remove electrical stimulations, 4) generate anotification, and 5) communicate a text-based message, video message,audio message, or graphic message to the user.

Referring back to FIG. 70, if a health trend is not determined orconfirmed at step 7012 then, at step 7016, the HMA evaluates ifadditional information or data is required from the user in order toconfirm an impending or ensuing health trend. If yes, then at step 7018,the HMA may automatically prompt the user for data inputs at specificpoints of time in the day to obtain the additional information or dataneeded to confirm or ascertain if a health trend exists or not.Optionally, the notification rate or frequency and timing may bemodified by the HMA in order to get additional or missing health relateddata or obtain the data necessary to confirm a pattern. Optionally, theHMA may prompt or warn after a predefined period, such as one day, thatthe user is not providing enough data to establish an appetite patternand that it will stimulate the user based on the predefined defaultstimulation or operational mode. In other words, according to aspects ofthe present specification, the notification rate or frequency ismodified based on historical user inputs of health related informationsuch as appetite or hunger. Thus, if user inputs in response tohistorical prompts regarding appetite, for example, are below apredefined threshold then the HMA may increase the rate or frequency offuture prompts. Conversely, if the user inputs in response to historicalprompts regarding appetite, for example, are above a predefinedthreshold then the HMA may increase the rate or frequency of futureprompts. One of ordinary skill in the art would appreciate that thevariation in prompt frequency may apply to hunger, satiety, satiation,fullness, caloric input, exercise input, among other variables.

Specifically, as data is gathered, the HMA evaluates the data todetermine if there is a trend. For example, it may be determined thatmore data is needed if appetite data for a particular window, such aswithin 1 hour of conventional lunch time (noon), varies by more than20%, as determined by a visual analog scale. In that case, it is unclearwhat the user's appetite is for key times of the day. In variousembodiments, the HMA may also assume that, where the user does notprovide, say, appetite/hunger data for example, then the appetite wasbelow a threshold amount. Based on the user's input of the additionalinformation or data, as a result of the prompt, the HMA may or may notascertain presence of a health trend and accordingly may or may notgenerate one or more interventions, at step 7020.

By way of a non-limiting example of steps 6016, 7020, the HMA monitoringor tracking the plurality of health related information or data of theuser may determine that the user's appetite level is above a predefinedthreshold at specific times of day, say at lunch time, for at least ‘W’days, say 2 days, in a row. However, the user could not provide inputsrelated to his well-being levels for one or all of the ‘W’ days. In theabsence of well-being related information or data, the HMA is unable toconfirm the health trend related to heightened appetite. Therefore, theHMA (companion device) automatically prompts the user for his well-beinglevels and if the subsequently inputted well-being levels also show adeteriorating trend, the HMA may conclude that a heightened appetiterelated health trend does exist. Based on this conclusion, the HMA mayautomatically generate and provide at least one of the plurality oftypes of interventions for the corresponding future time windows withinwhich the pattern occurs.

However, at step 7016, if the HMA determines that no additionalinformation or data is required from the user in order to confirm ahealth trend then, at step 7022, the HMA does not generate anyintervention and continues to continuously or periodically analyze theuser's plurality of health related information to identify one or morehealth trends.

In accordance with an aspect, after generating and providing anintervention to the user, the HMA may query the user if he is satisfiedwith the intervention. If the user is not satisfied with theintervention, the user may be immediately prompted about his appetite orhunger data at that time and/or may be presented with a differentintervention. For example, if the first intervention comprised coachingadvice, the second intervention may comprise a modification ofelectrical stimulation parameters, prompted by a patient input thatindicates the patient is not satisfied with the intervention.

Various embodiments also comprise triggering real-time stimulation basedon the user's expressed request or need in addition to or in lieu of thestandard stimulation protocol pre-configured settings (for example mild,optimal, intense) and/or in addition to or in lieu of the automaticstimulation modulation or titration based on identification orconfirmation of one or more health trends. On-demand stimulations, alsoreferred to hereinafter as “rescues” or “rescue sessions”, are appliedat the onset of unplanned or unscheduled hunger events and/or at apotential occurrences of hunger events as known from the user's hungerprofile.

In various embodiments, the rescue sessions are initiated manually bythe user in a plurality of ways, such as, but not limited to; by shakingmotion of his smartphone that, in some embodiments, works as thecompanion device 105 of FIG. 1A; by issuing voice based commands to theHealth Management Application (HMA) via an Intelligent PersonalAssistant (IPA) system described with reference to FIG. 48A through C;by actuating a button on the EDP device itself or on a remote toggleswitch configured to be worn around the user's neck or placed on hiswrist in the form of a wristwatch or wristband; by issuing commandsthrough pre-defined physical body movements, such as (for example)haptic motions of the wrist or hand, when the user is wearing awristwatch or wristband (that includes an accelerometer or inclinometerto detect, capture and acquire the user's haptic motions). In otherembodiments, the rescue sessions are automatically triggered, such as,by using the IPA system (configured as a Bluetooth speaker, for example)to sense the presence of the EDP device (worn by the user) within a foodconsumption area—for example, kitchen—as described earlier withreference to FIG. 48A through C. In some embodiments, the HMA, installedon the user's smartphone, utilizes the GPS sensor of the smartphone todetermine if the user is in a restaurant, for example. If the user isfound to be visiting a restaurant and it is not a meal time, the user isprompted for and delivered a rescue session. In still other embodiments,the rescue sessions are triggered by user action on a third party device(including a third party application software on an external device),with physiological sensors, configured to be worn on the human body,such as around the wrist, in order to monitor, acquire, record, and/ortransmit the physiological data, to receive and integrate exercise andweight loss information.

In a preferred embodiment, demand for a rescue session is initiated byactuating a button on the user's smartphone that functions as thecompanion device 105 of FIG. 1A. In some embodiments, the button isphysical such as a designated key on the smartphone while in otherembodiments, the button is virtual such as a software-based icon on thesmartphone. It is possible that the user may actuate the button multipletimes, such as, by repeatedly pushing or clicking the button. Tosafeguard against such cases, repeated or multiple actuations areregistered or counted as a single actuation if the repeated or multipleactuations occur within a predetermined time range (on the order ofseconds or minutes) of each other. Actuating the button (such as bypressing the physical button or the software icon), in some embodiments,activates a light bar configured as a 0 to 10 point Visual Analog Scale(VAS) wherein 0 represents absence of any hunger and 10 represents themost intense level of hunger. FIG. 51 is a depiction of a graphical userinterface with a visual light bar. It should be noted herein that whileFIG. 51 is described in terms of a light bar having a scale from 0 to10, any range may be employed, and any incremental iteration maycorrespond to any therapeutic length of time, in accordance with thepresent specification. For example, a range of 0 to 100 may be selectedfor the light bar to denote a patient's degree of hunger.

As shown in FIG. 51, the light bar VAS 5100 extends or progresses, from0 at the far left 5102 of the scale to 10 at the far right 5104 of thescale depending upon how long the user presses the button. In otherwords, the longer the user presses the button, the longer the light barextends. In an embodiment, the closer to 10 that the light barprogresses from 5102 to 5104, the darker it becomes. In an embodiment,the user may repeatedly press light bar 5100 on a touchscreen deviceuntil the appropriate degree of hunger is selected. In anotherembodiment, the user may slide the light bar 5100 from right to left orleft to right, on a touchscreen device, to indicate the degree ofhunger.

In accordance with an aspect, the length or extent of the light bar VASis not only indicative of the level of hunger of a hunger event but isalso indicative of the duration of a potential rescue session that maybe triggered. In some embodiments, the length or extent of the light barVAS is equal to the duration of the rescue session. Thus, a light barVAS length representative of 7 (on the 0 to 10 VAS, for example) wouldtrigger 7 minutes of rescue session therapy, a light bar VAS lengthrepresentative of 8 would trigger 8 minutes of rescue session therapyand so on up to a maximum of 10 minutes of rescue session correspondingto a maximum light bar VAS length representative of 10. In accordancewith an embodiment, a threshold or minimum actionable hunger levelrequired to trigger any rescue session is set at 5 (that is, themidpoint of the light bar VAS). Thus, a light bar VAS lengthrepresentative of 5 would trigger 5 minutes of rescue session therapy.However, light bar VAS lengths representative of hunger levels of lessthan 5, that is the levels of 0, 1, 2, 3 or 4, would register as lowintensity hunger events but would not trigger a rescue session. In someembodiments, high levels of hunger on the light bar VAS (such as thosegreater than 6, for example) could trigger proportionally higheramplitude of rescue stimulation in conjunction or in lieu of longerrescue stimulation times.

It should be appreciated that the threshold or minimum actionable hungerlevel required to trigger any rescue session is set at 6, in alternateembodiments. In such alternate embodiments, light bar VAS lengthsrepresentative of hunger levels of less than 6, that is the levels of 0,1, 2, 3, 4 or 5, would register as low intensity hunger events but wouldnot trigger a rescue session.

In some embodiments, depending on the hunger intensity of the user anyone of the following can happen: a) no stimulation because intensitylevel is below the threshold, b) hunger intensity level is above thethreshold but below 8 that may trigger a rescue session of 15 minutes at10 mA, c) hunger intensity level is above 8 that may trigger a rescuesession of 15 minutes at 20 mA.

In some embodiments, the duration of the rescue session is proportionalto the length or extent of the light bar VAS. For example, a VAS hungerintensity level of 7 (on a scale of 0 to 10) may trigger a proportionaterescue stimulus of, say, 10 minutes at 20 mA whereas a VAS hungerintensity level of 6 may trigger a proportionate rescue stimulus of,say, 5 minutes at 15 mA. A VAS hunger intensity level less than 6 (orless than 5, in alternate embodiments) may not trigger any rescuesession.

In still other embodiments, the duration of the rescue session isproportional to the actual caloric intake (or caloric intensity) by thepatient. Consider scenarios where the patient records caloric intake orconsumption that exceeds planned consumption—for example, the actualcaloric consumption of the patient at lunch is 800 calories instead of aplanned 600 calories. Therefore, in such scenarios the patient isdelivered a post-prandial rescue session which is proportionate to thecaloric consumption of the patient.

While the user is allowed on-demand stimulations as well as customizedstimulation protocols, in various embodiments the Health Managementapplication is programmed to ensure (such as by continuous monitoring,limited or restricted control access to only the subset of stimulationparameters and/or restricting the user control access to only aconstrained range within the standard settings ranges) that the userdoes not over or under stimulate, thereby resulting in habituation orineffective stimulation. For example, the user may be allowed to add tothe number of daily sessions, over and above those scheduled based onthe standard protocol settings such as mild, optimal, intense orbaseline stimulation protocol, but subject to some limitations orrestrictions. For example, the user may have five additional “rescues”in the first month of the stimulation therapy, declining to 4 daily inthe second month, and 3 daily in the third month of therapy. It shouldbe appreciated that the limitations are critical to avoiding habituationover time. Also, the number of stimulation sessions may be restrictedand then may decline and/or the stimulation intensity, such as theamplitude and frequency, may be allowed to be adjusted up or down by aset amount, for example by +/−10%. In some embodiments, the user isallowed up to 12 rescue sessions per day of short duration, say, 5minutes.

In one embodiment, the user is allowed a daily total rescue budget of amaximum of, say, 60 minutes of rescue therapy that can be delivered in aminimum of 5 minutes and a maximum of 10 minutes boluses or rescuesessions—at an amplitude similar to the baseline stimulation protocol.Accordingly, the users are allowed a maximum of 12 rescue sessions of 5minutes each (12×5 minutes) and a minimum of 6 rescue sessions of 10minutes each (6×10 minutes) on a daily basis. Thus, in context of usingthe light bar VAS, the user can record an unlimited number of low levelhunger events, but only a maximum budget of 60 minutes of actual rescuetherapy, with no bolus shorter than 5 minutes. In an alternateembodiment, 60 minutes of rescue therapy can be delivered in 15 minutesof boluses or rescue sessions thereby allowing 4 rescue sessions of 15minutes each (4×15 minutes). It should be appreciated that, in alternateembodiments, the daily total rescue budget may be defined in terms ofminimum and maximum stimulation amplitude, frequency or number of rescuesessions within a stipulated period of time.

In another embodiment, the user is allowed a daily total rescue budgetof a maximum of, for example, 90 minutes of rescue therapy that can bedelivered in a minimum of 15 minutes boluses or rescue sessions—at anamplitude similar to the baseline stimulation protocol. Accordingly, theusers are allowed a maximum of 6 rescue sessions of 15 minutes each(6×15 minutes) on a daily basis. In some embodiments, the daily totalrescue budget of a maximum of 60 or 90 minutes can only be used betweenmeals, such as, for example, more than 30 minutes prior or 90 minutesafter a meal.

In one embodiment, the user is allowed a daily number of stimulationsof, for example, 10 that can be delivered in default preprogrammedstimulations and/or real-time rescue sessions delivered in response to apatient's request. Before generating a rescue session, the systempreferably analyzes the total number of stimulations delivered in aprevious time period, such as 24 hours or less, and determines whether,and how many, stimulation sessions may be provided based on acombination of the number of pre-programmed stimulations and real-timerescue sessions being requested.

In embodiments, the daily total rescue budget is comprised of at leasttwo components—a first component being the daily discretionary rescuebudget and a second component being the daily automatic rescue budget.The daily discretionary rescue budget restricts the rescue sessions thatthe user is allowed to have according to his choice or discretion whilethe daily automatic rescue budget restricts the rescue sessions that theuser is automatically delivered as a result of the user's history orpattern of unplanned or unscheduled hunger events. In some embodiments,the daily total rescue budget is set at, for example, 60 minutes whilethe daily discretionary and automatic rescue budgets are set at, forexample, 30 minutes each. In alternate embodiments, the daily totalrescue budget may be set at lesser or higher values and the dailydiscretionary and automatic rescue budgets may also comprise differentpercentages of the total rescue budget. In embodiments, where the dailytotal rescue budget is of a maximum of 90 minutes of rescue therapy, thedaily discretionary and automatic rescue budgets are set at, forexample, 45 minutes each.

In accordance with an aspect of the present specification, the hungerevents, levels and the triggered “rescue sessions” are tracked (date andtime stamped, including duration of each rescue session) and recorded(such as through the light bar VAS) to generate the user'sindividualized hunger profile or hunger map, over a predefined period oftime and/or a predefined number of rescue sessions. In variousembodiments, the predefined period of time ranges from a few days, say 5to 7 days, to weeks, say 3 to 6 weeks. In various embodiments, thepredefined number of rescue sessions ranges from 1 to 10 sessions. Itshould be appreciated that one or more threshold or filter conditions,such as but not limited to, the predefined period of time and/or numberof rescue sessions are defined so as to achieve a sufficient level ofconfidence that the rescue sessions represent a pattern of hunger andnot one-off random events.

The user's individualized hunger profile or map is dynamic andindicative of occurrences of events when the user actually feels hungryor is thinking about food and, in some embodiments, is representative ofhunger spikes for the user. Therefore, in various embodiments, theuser's individualized hunger profile is utilized to automaticallycustomize, modify, drive and deliver stimulation therapy or protocol totarget the user's hunger spikes. In other words, the variable number ofdaily rescue sessions are interpreted as the user's hunger or satietylevel on a given day and used to create the user's individualized hungermap for that day, for example, showing the timing and/or intensity ofhunger clusters. This hunger map is then be used to automaticallytitrate and time stimulation therapy. For example, in some embodiments,the threshold or filter conditions (to ascertain a pattern of hunger)may constitute or be defined as a minimum of, for example, 3 hungerevents (each triggering a rescue session or bolus—that is, each of the 3hunger event being of an intensity level greater than or equal to 5 on a0 to 10 light bar VAS) recorded on 3 separate days in the same week andwithin, say, 60 minutes of the same time of day. Thus, meeting of thethreshold or filter conditions may, for example, trigger an automatic 10minutes rescue session or bolus at that time in subsequent week(s).

The user's individualized hunger profile or map represent a dynamicrecord of daily and weekly appetite trends and are therefore tracked andgenerated throughout the treatment cycle of the user. The dynamic hungerprofile or map can be shown to the user daily and/or weekly and used asa measure or record of daily hunger intensity and distribution and,therefore, stimulation treatment progress over time. In someembodiments, the user's daily weight graph, as it evolves during astimulation therapy, is overlaid or juxtaposed with the user'sindividualized hunger map to communicate treatment progress. The user'sdaily weight trend and hunger profile are utilized to titrate or triggertherapy as well as enable automated coaching so as to provide advice andencouragement to the user based on their performance and compliance. Theuser's individualized hunger profile or map is communicated to the user,affinity groups, physician, and an automated dietary coach or conciergeservice.

In some embodiments, the Health Management application continuouslymonitors, to titrate therapy accordingly, the user's glycemic indicator,such as, but not limited to, glucose level or glucose status data—in aclosed loop configuration wherein glucose level, status data or data isobtained or received by the Health Management application by at leastone of the following means: using a continuous glucose sensor integratedwith the EDP as one of the sensors 135 of FIG. 1A, allowing the user tomanually input glucose data using a VAS light bar at predeterminedintervals (and/or as may be prompted by the HMA), allowing the user toverbally input glucose level at predetermined intervals via an IPAsystem (and/or as may be prompted by the IPA) in communication with theHealth Management application, or using a third party device—whether itis a third party application software on an external device or a secondexternal device entirely (such as, but not limited to, a watch, a pairof smart shoes, a diabetes wearable pump, or another medicaldevice)—comprising a continuous glucose sensor alone or in combinationwith a plurality of physiological sensors and in communication with theHMA (via pairing or syncing). It should be appreciated that in someembodiments the HMA is installed or embedded on the third party deviceitself thereby obviating the need for a separate companion device.

Depending upon the received glucose data, a time of day and/or based onsuch historic glucose data as well as other current and/or historichealth related information such as, but not limited to, the currentand/or historic meal profile or the current and/or historic degree ofappetite or hunger, the HMA may recommend (for user approval) orautomatically commence (if pre-approved or pre-authorized by the user) amodified stimulation therapy (such as, modified timing, duration, numberand/or intensity of stimulation sessions). For example, referring to aflow chart of FIG. 62, a user's glucose level or glucose status data isacquired by the HMA at step 6205. At step 6210, if it is determined thatthe user's glucose status data is higher than the normal, by apredefined glucose threshold, for example the glucose status data isequal to 200 mg/dl or higher, the HMA may program the EDP (in otherwords, the HMA generates and communicates a modulation signal to theEDP), at step 6215, to deliver a stimulation session of, e.g., 15minutes duration at 20 mA intensity. If the glucose status data is notgreater than 200 mg/dl, no stimulation session is delivered and the HMAcontinues to periodically and automatically monitor the user's glucosestatus data. In one exemplary scenario, at step 6220 a, if after apredefined interval, e.g. an hour, it is determined that the user'sglucose level is still high (e.g., greater than or equal to 200 mg/dl)the HMA, at step 6225, may re-program the EDP to deliver one or moresubsequent stimulation sessions at increased therapy duration as well asintensity (for example). If, after the stimulation session and thepredefined interval, the glucose status data is no longer greater than200 mg/dl, the HMA does not reprogram the EDP to deliver one or moresubsequent stimulation sessions but rather continues to periodically andautomatically monitor the user's glucose status data.

In another exemplary scenario, at step 6220 b, if after a predefinedinterval it is determined that the user's glucose level has lowered byat least 1% (compared to the glucose level before stimulation) the HMA,at step 6230, enables the EDP to continue stimulation at a predefinedminimum amplitude and/or intensity either for a predefined fixedduration of time or until the user's glucose level returns to normallevels. If, after the stimulation session and the predefined interval,the user's glucose level has not lowered by at least 1% (compared to theglucose level before stimulation), the HMA does not enable the EDP tocontinue stimulation but rather continues to periodically andautomatically monitor the user's glucose status data. In someembodiments, stimulation session(s) and titration of therapy protocolsand/or patterns may be accompanied with cautionary alarms or feedback(audio, visual and/or tactile) to the user recommending the user to stopeating, for example when the glucose levels are observed to remain highfor a period of time.

FIG. 63 is a flow chart illustrating a plurality of exemplarystimulation protocols followed once a user's glucose level or glucosestatus data is acquired by the HMA at step 6305. In one exampleprotocol, at step 6310 a, if the user's glucose level is greater than100 mg/dl upon waking in the morning, the HMA may program the EDP todeliver at least one stimulation session to create fullness (equivalentto, say, a hunger level of less than 6 on a hunger scale of 0 to 10) foran extended period of time (in order to achieve a fasting state),wherein the extended period of time is at least 5 minutes. In anotherexample protocol, at step 6310 b, if the user's glucose level is above140 mg/dl at any time of day, the HMA may program the EDP to deliver atleast one stimulation session to reduce or suppress hunger to a levelbelow 6 (on a hunger scale of 0 to 10) to prevent the user fromovereating. In another example protocol, at step 6310 c, the HMA mayprogram the EDP to deliver at least one stimulation session so that theuser's glucose level reaches a predefined minimum, such as 80 mg/dl,before the user feels sufficient hunger to eat. In yet another exampleprotocol, at step 6310 d, the HMA may program the EDP to deliver atleast one stimulation session at night, e.g. past 7 pm, so that theuser's glucose level is less than 100 mg/dl in the morning. In stillanother example protocol, at step 6310 e, the HMA may program the EDP todeliver at least one stimulation session so that the user's rate ofglucose is maintained at less than 2 mg/dl per minute.

FIG. 64 is a flowchart illustrating steps of a method of titratingstimulation therapy based on at least a glucose status data of a user,in accordance with an embodiment of the present specification. At step6405, a user wears an EDP device of the present specification which isin communication with a separate companion or client device implementinga Health Management application (HMA) of the present specification. TheEDP device is configured to generate a plurality of stimulation sessionscomprising a plurality of electrical pulses defined by stimulationparameters such as, but not limited to, a session frequency, a sessionduration, a pulse width in a range of 10 μsec to 10 msec, a pulseamplitude in a range of 100 μA to 100 mA, and a pulse frequency in arange of 1 Hz and 100 Hz. At step 6410, the HMA acquires or receives theuser's glucose status data or level using at least one of the followingmeans: a) using a continuous glucose sensor integrated with the EDP asone of the sensors 135 of FIG. 1A to periodically and automaticallymonitor and record the user's glucose status data, b) by prompting theuser, at predetermined intervals (and/or as may be prompted by the HMA),to input glucose status data by causing a VAS (visual analog scale)light bar to be displayed on the client device, c) allowing the user toverbally input glucose status data at predetermined intervals via an IPAsystem (and/or as may be prompted by the IPA) in communication with theHealth Management application, or d) using a third party device, toperiodically and automatically acquire the user's glucose status dataand wirelessly communicate the glucose status data to the client device.The third part device may include a third party application software onan external device or a second external device entirely (such as, butnot limited to, a watch, a pair of smart shoes, a diabetes wearablepump, or another medical device)—comprising a continuous glucose sensoralone or in combination with a plurality of physiological sensors and incommunication with the HMA (via pairing or syncing).

It should be appreciated that the user's glucose status data acquired orreceived by the HMA is time stamped to associate a time of day to themonitored glucose status data. In some embodiments, the HMA acquires orreceives the glucose status data at specific and predetermined times ofday that are then associated with the acquired glucose status data andstored.

At step 6415, the HMA prompts the user to input his degree of appetiteor hunger. In various embodiments, the user is prompted via an IPAsystem in communication with the HMA, through a microphone/speakersystem of the client device and/or a display of the client device. Theuser may be prompted to input his degree of appetite at a predeterminedschedule such as before and/or after scheduled or planned meals (like,breakfast, lunch and dinner), in association with a time of day when theuser's glucose status data is acquired or received by the HMA and/ordepending upon a need determined by the HMA based on an acquired orreceived glucose status data.

At step 6420, the HMA generates a modulation signal (to titratestimulation protocols and/or parameters) based on any one or acombination of the acquired or received glucose status data, a time ofday and a data indicative of the user's degree of appetite or hunger. Atstep 6425, the modulation signal is transmitted to the EDP. It should beappreciated that the modulation signal comprises a plurality ofstimulation parameters and/or protocols that cause a glycemic indicatorof the user to improve relative to the user's glycemic indicator priorto applying the modulation signal. In various embodiments, the glycemicindicator may include indicators such as, but not limited to, glucoselevel, a level of hemoglobin A1C, hepatic gluconeogenesis, a degree ofinsulin resistance, level of glucose homeostasis and a level of HOMA-IR(see section titled ‘Therapeutic Objectives’ of the specification forimprovement objectives related to various glycemic indicators).

FIG. 65 is a flowchart illustrating steps of a use case of titratingstimulation based on at least a glucose status data of a user, inaccordance with an embodiment of the present specification. At step6505, the HMA acquires or receives a user's glucose status data before11 am in the morning. The HMA examines, at step 6510, if the acquired orreceived glucose status data is greater than 100 mg/dl. If the glucosedata is greater than 100 mg/dl then, at step 6515, the HMA generates andcommunicates a modulation signal to the EDP, wherein the modulationsignal is configured to cause the electrical dermal patch to generate anelectrical stimulation after 5 pm. It should be appreciated that themodulation signal comprises at least one of an increased second sessionfrequency relative to a previous session frequency, an increased secondsession duration relative to a previous duration, an increased secondpulse amplitude relative to a previous pulse amplitude, and an increasedsecond pulse frequency relative to a previous pulse frequency. If theglucose status data is not greater than 100 mg/dl no modulation signalis generated and the HMA continues to periodically and automaticallymonitor the user's glucose status data.

FIG. 66 is a flowchart illustrating steps of another use case oftitrating stimulation based on at least a glucose status data of a user,in accordance with an embodiment of the present specification. At step6605, the HMA acquires or receives a user's glucose status dataperiodically throughout a day. The HMA examines, at step 6610, if theacquired or received glucose status data is greater than 140 mg/dl. Ifthe glucose data is greater than 140 mg/dl then, at step 6615, the HMAgenerates and communicates a modulation signal to the EDP, wherein themodulation signal is configured to cause the electrical dermal patch togenerate an electrical stimulation within two hours after determiningthe glucose level is greater than 140 mg/dl. If the glucose status datais not greater than 140 mg/dl no modulation signal is generated and theHMA continues to monitor the user's glucose status data throughout theday.

FIG. 67 is a flowchart illustrating steps of another use case oftitrating stimulation based on at least a glucose status data of a user,in accordance with an embodiment of the present specification. At step6705, the HMA acquires or receives a user's glucose status dataperiodically throughout a day. The HMA examines, at step 6710, if theacquired or received glucose status data is greater than 140 mg/dl. Ifthe glucose data is greater than 140 mg/dl then, at step 6715, the HMAalso examines data indicative of the user's degree of appetite orhunger. It should be appreciated that the HMA may examine a last storeddegree of appetite (from the user's daily diary inputs) and/or promptthe user to acquire (immediately upon acquiring or receiving the glucosestatus data or at a predetermined later time or after a time interval) acurrent degree of appetite or hunger. If the glucose data is greaterthan 140 mg/dl and the degree of appetite is also greater than apredefined threshold or number then, at step 6720, the HMA generates andcommunicates a modulation signal to the EDP, wherein the modulationsignal is configured to cause the electrical dermal patch to generate anelectrical stimulation within a predefined time, such as two hours,after determining the glucose level is greater than 140 mg/dl and theuser's degree of appetite is greater than the predefined number. If theglucose status data is not greater than 140 mg/dl and/or the user'sdegree of appetite is not greater than the predefined number, then nomodulation signal is generated and the HMA continues to monitor theuser's glucose status data throughout the day.

FIG. 68 is a flowchart illustrating steps of yet another use case oftitrating stimulation based on at least a glucose status data of a user,in accordance with an embodiment of the present specification. At step6805, the HMA acquires or receives a user's glucose status data. The HMAexamines, at step 6810, if the acquired or received glucose status datais less than 80 mg/dl. If the glucose data is less than 80 mg/dl then,at step 6815, the HMA generates and communicates a modulation signal tothe EDP. It should be appreciated that the modulation signal comprisesat least one of a decreased second session frequency relative to aprevious session frequency, a decreased second session duration relativeto a previous duration, a decreased second pulse amplitude relative to aprevious pulse amplitude, and a decreased second pulse frequencyrelative to a previous pulse frequency. If the glucose status data isnot less than 80 mg/dl no modulation signal is generated and the HMAcontinues to monitor the user's glucose status data.

FIG. 69 is a flowchart illustrating steps of still another use case oftitrating stimulation based on at least a glucose status data of a user,in accordance with an embodiment of the present specification. At step6905, the HMA acquires or receives a user's glucose status data. The HMAexamines, at step 6910, if a rate of increase in a glucose level of thepatient is more than 2 mg/dl per minute. If the rate is more than 2mg/dl per minute then, at step 6915, the HMA generates and communicatesa modulation signal to the EDP. It should be appreciated that themodulation signal comprises at least one of an increased second sessionfrequency relative to a previous session frequency, an increased secondsession duration relative to a previous duration, an increased secondpulse amplitude relative to a previous pulse amplitude, and an increasedsecond pulse frequency relative to a previous pulse frequency. If therate is not more than 2 mg/dl per minute no modulation signal isgenerated and the HMA continues to monitor the user's glucose statusdata.

In some embodiments, the Health Management application is configured tobe in communication with an insulin pump that the user may be using toinfuse insulin while the electro-dermal patch device of the presentspecification uses a continuous glucose sensor, as one of the sensors135 of FIG. 1A or as a standalone third party device in wirelesscommunication with the HMA, to continuously monitor the user's glucoselevel in a closed loop configuration. Thus, for example if the user'sglucose level is higher than the normal, by a predefined glucosethreshold, the Health Management application may recommend commencingwith the optimal or intense stimulation protocol along with a diet plan,such as that illustrated in Table 3, for a period of 2 weeks. In someembodiments, the HMA may be pre-configured or pre-authorized by the userto automatically trigger the optimal or intense stimulation protocol ifthe user's glucose level is found to be higher than the normal. Invarious embodiments, a predefined glucose threshold comprises a fastingblood sugar level greater than 80 mg %. The Health Managementapplication continuously monitors the user's glucose levels during thetherapy and allows the user to suppress post-prandial glucose levels.When it is found that, due to the stimulation therapy, the user'sglucose levels are gravitating towards normal levels the HealthManagement application communicates this information to the user'sinsulin pump to slow the insulin delivery/infusion. As discussedearlier, the stimulation protocol may be automatically adjusted to mild,optimal, intense or the stimulation therapy may be completely stoppeddepending upon the effect on the glucose levels of the user. It shouldbe appreciated that while in some embodiments the HMA is pre-configuredor pre-authorized by the user to automatically titrate stimulationtherapy (that is, start, stop or adjust stimulation protocol) dependingon the monitored glucose level, in alternate embodiments the HMArecommends a relevant stimulation therapy or protocol (for example,mild, optimal, intense or complete stop stimulation) to the user whothen accepts the recommendations subsequent to which the acceptedstimulation therapy or protocol is initiated.

In some embodiments, the electro-dermal patch device of the presentspecification is sized in the form of a skin patch that covers both ofthe T6 and T7 dermatomes. In alternate embodiments, the user may use afirst electro-dermal patch on the T6 dermatome and a secondelectro-dermal patch on the T7 dermatome. In such cases, the HealthManagement application alternatingly stimulates the T6 and T7 dermatomesto treat conditions of obesity, over-weight, eating disorders, metabolicsyndrome as well as T2DM. In some embodiments, the electro-dermal patchdevice of the present specification is sized to cover both of the C8 andT1 dermatomes (as shown in FIG. 19C). In alternate embodiments, the usermay use a first electro-dermal patch device on the C8 dermatome and asecond electro-dermal patch device on the T1 dermatome. In such cases,the Health Management application alternatingly stimulates the C8 and T1dermatomes to treat conditions of obesity, over-weight, eatingdisorders, metabolic syndrome. In various embodiments, a plurality ofelectro-dermal patch devices of the present specification are used tocover T6, T7, C8 and/or T1 dermatomes that are simultaneously oralternatingly stimulated to conditions of obesity, over-weight, eatingdisorders, metabolic syndrome and/or T2DM.

It should be noted, that the various suggestions and recommendationsauto generated by the Health Management application, for initial freshstimulation protocols, patterns and parameter settings as well as thoserelated to adjusting these stimulation protocols and settings may, invarious embodiments, be implemented by the user only after an approvaland advice from the remote patient care facility and/or personnel. Insome embodiments, however, prior approval from the remote patient carefacility or personnel may not be required. The Health Managementapplication enables the user to set an option of prior approval ordisable this option.

In some embodiments, the electro-dermal patch device is driven bystimulation algorithms having different stimulation parameters to treatconditions of obesity, over-weight, eating disorders, metabolic syndromeby first enabling the patient to lose excess weight and then maintainthe weight loss. For example, in one embodiment, the patient isstimulated with a first stimulation algorithm to induce weight loss.Once the patient has reached a target weight, the stimulation algorithmis changed to a second stimulation algorithm to maintain the weightloss. In some embodiments, the total stimulation energy per day providedby the first algorithm to induce weight loss is greater than the totalstimulation energy per day provided by the second algorithm to maintainweight loss.

Example Stimulation Protocols for Managing Habituation, Nausea,Dyspepsia, and Skin Irritation

Habituation refers to a decrease in sensory perception of a stimulusafter prolonged presentation of the stimulus. In various embodiments ofthe present specification, in order to overcome habituation, thestimulation intensity is designed to gradually increase or decreasethroughout the entire therapy session, in contrast to prior artpractices of requiring the patient to manually increase or decreaseintensity periodically during the therapy session. The presentspecification also learns the manner and frequency of the manualadjustment of the desired stimulation intensity so as to customize thestimulation parameters that modify stimulation in order to combathabituation.

In accordance with an exemplary embodiment, the stimulation intensity(comprising the pulse amplitude and/or frequency) is increased ordecreased arithmetically (that is, linearly) or geometrically (that is,exponentially) with time. It should be noted, that an increase in thestimulation intensity is always above the user's ‘sensory threshold’(which is already determined prior to stimulation sessions) and adecrease in the stimulation therapy is constrained in that thestimulation intensity is not allowed to fall below the ‘sensorythreshold’. As an example, for geometric increase or decrease, thestimulation intensity is multiplied or divided by a fixed factor perunit time. For example, the stimulation intensity may be geometricallyincreased or decreased by a factor Z, wherein Z is say 1.004 as anexample, for every minute of a therapy session. This equates to anapproximately 27% increase or decrease in stimulation intensity over a60 minute therapy session. In various embodiments, ‘Z’ comprises a 10%to 50% increase or decrease of any given parameter. In anotherembodiment, the stimulation intensity is linearly increased or decreasedby a fixed amount, such as 0.5 mA, for every minute of the therapysession. In another embodiment, the rate of increase or decrease isadjusted to account for manual changes in the stimulation intensity. Forexample, if the user decreases the stimulation intensity in the middleof the therapy session, then the automatic rate of increase may be toohigh for this user and should be decreased for subsequent therapysessions. Similarly, if the user increases the stimulation intensity inthe middle of the therapy session, then the automatic rate of increasemay be too low for this user and should be increased for subsequenttherapy sessions. In this fashion, the automatic habituationcompensation is adaptive and responsive to the user's physiology.

In further embodiments, the stimulation continuity profile may be astep-up or a step-down profile wherein the stimulation amplitude and/orfrequency may increase or decrease on a per session basis and/or thenumber of stimulation sessions per day may increase or decreasethroughout the duration of a stimulation therapy or course to combathabituation.

In various embodiments, if the user feels nausea or dyspepsia before,during and/or after stimulation sessions he may provide an input to theHealth Management application that a nausea and/or dyspepsia eventoccurred which is then automatically time stamped and stored by theapplication to generate and display a dynamic well-being profile or mapof the user.

In a preferred embodiment, a nausea and/or dyspepsia event—constitutingthe well-being parameter—is recorded by actuating a button on the user'ssmartphone that functions as the companion device 105 of FIG. 1A. Insome embodiments, the button is physical such as a designated key on thesmartphone while in other embodiments, the button is virtual such as asoftware-based icon on the smartphone. Actuating the button (such as bypressing the physical button or the software icon), in some embodiments,activates a light bar configured as a 0 to 10 point Visual Analog Scale(VAS) wherein 0 represents no nausea and/or dyspepsia (that is, thehighest level of well-being) and 10 represents the most intense level ofnausea and/or dyspepsia (that is, the worst level of well-being).

The light bar VAS extends or progresses depending upon how long the userpresses the button. In other words, the longer the user presses thebutton, the longer the light bar extends. In accordance with an aspect,the length or extent of the light bar VAS is indicative of the level orintensity of nausea and/or dyspepsia experienced. In accordance with anembodiment, a threshold or minimum actionable nausea and/or dyspepsialevel is set at 4 on the VAS. Thus, a light bar VAS lengthrepresentative of a level of nausea and/or dyspepsia at or below 3 (thatis, levels 1, 2 or 3) would not trigger any action. However, light barVAS lengths representative of nausea and/or dyspepsia levels of 4 andabove would register as high intensity, and therefore, actionable nauseaand/or dyspepsia or negative well-being event.

As a result of occurrence of an actionable nausea and/or dyspepsiaevent, the Health Management application may modify an existingstimulation protocol, for example may recommend switching the currentintense stimulation protocol to the mild stimulation protocol if, forexample, the nausea and/or dyspepsia intensity ranges between 7 and 9.Additionally or alternatively, the stimulation continuity profile may beswitched to the step-down profile. Still further, the Health Managementapplication may recommend pausing the stimulation sessions for one ormore days before restarting with a step-down stimulation protocol. Inyet another embodiment, the Health Management application may recommendpausing the stimulation sessions as well as not allowing any rescuesessions for one or more days before restarting with a step-downstimulation protocol. For example, in one embodiment, any single nauseaand/or dyspepsia event at an intensity of 10 on the VAS scale willimmediately cause all subsequent therapy sessions to be stopped and theuser prompted to call their physician. In another example, if the userrecords K number of nausea and/or dyspepsia events of intensity between4 and 6, within L period of time the HMA may switch the stimulationcontinuity profile to the step-down profile. In another embodiment, forexample, any cumulative actionable VAS score of 15 in the same week—thatis, a score of a 4, and a 5 and a 6 would, in combination, cause theHealth Management application to shut down therapy. In yet anotherembodiment, any actionable cumulative score in the same week greaterthan 10 would cause the Health Management application to reduce thebaseline therapy sessions from 30 to 15 minutes each (that is, a totalof 15 minutes×3 daily sessions=45 minutes per day rather than thebaseline 30 minutes×3 daily sessions=90 minutes per day). In thisembodiment, if the frequency of such actionable nausea and/or dyspepsiaevents continues, the therapy is terminated.

In various embodiments, modification of an existing stimulation protocolis affected at night when the user is in bed. In accordance with anaspect, the HMA enables the user to not only input and record a nauseaand/or dyspepsia event but also input additional information such as howlong the event lasted and presenting a GUI screen to the user, after apredefined period of time has elapsed since recordation of a nauseaand/or dyspepsia event, to check and record if the user is still feelingthe same way. If the user reports that he is still feeling the nauseaand/or dyspepsia, even after the predefined period of time, the HMAprompts the user to meet or get in touch with his physician and alsosend a notification to the user's physician or remote care facility.

In accordance with an exemplary embodiment, the electro-dermal patchdevice of the present specification generates biphasic, symmetrical,rectangular pulses with regulated current. This pulse waveform ischarge-balanced which prevents iontophoretic build-up under theelectrodes that can lead to skin irritation and potential skin damage.In accordance with another exemplary embodiment, the EDP devicegenerates biphasic, asymmetrical charge-balanced pulses with regulatedcurrent. Thus, in various embodiments, the EDP device generates pules topulse flipped symmetrical or asymmetrical, biphasic, charge-balancedpulses. Regulated current pulses provide more stable stimulation thanregulated voltage pulses, because the stimulation current is independentof the electrode-skin impedance, which typically changes during thecourse of a therapy session. In order to address a wide variety of skintypes and electrode quality (due to repeat use and air exposure), themaximum output voltage is 100V and the maximum output current is 50 mA.Finally, the pulse pattern is continuous stimulation with randomlyvarying inter-pulse intervals such that the frequency of stimulation hasa uniform probability distribution between 50 Hz and 150 Hz.Alternatively, the frequency of stimulation may have a Gaussianprobability distribution between 50 Hz and 150 Hz, or some otherprobability distribution. The benefit of providing frequency stimulationwith randomly varying inter-pulse intervals (versus frequencystimulation with constant inter-pulse intervals) is that the former typeof stimulation may lead to less nerve habituation.

Still further embodiments may involve relocating the electro-dermalpatch device from the first stimulation spot to a second spot andalternating between the first and second stimulation spots to avoidhabituation, skin irritation, nausea and/or dyspepsia.

In accordance with some embodiments, stimulation sensation experiencedby the user is modulated by modifying the waveform of the deliveredpulses without modifying the pulse amplitude by more than 10%.Accordingly, in embodiments, the EDP device delivers electricalstimulation at, say, amplitude of 20 mA with biphasic current and afirst waveform wherein the first waveform is a sloping waveform 5905 asshown in FIG. 59A. It should be appreciated that while the firstwaveform may provide a comfortable and therapeutically effective sensorystimulation to the user, this may not be therapeutically effective or bebelow “sensory threshold” for a different user. In accordance withaspects of the present specification, rather than substantiallyincreasing the amplitude of stimulation—which may increase the risk ofnausea, dyspepsia and/or habituation—the waveform of the electricalstimulation is modified to a second waveform wherein the second waveformis a square waveform 5910 as shown in FIG. 59B.

Accordingly, in one embodiment, a first pulse shape is modified to asecond pulse shape in response to a determination that the stimulationcomprising the first pulse shape is not sufficiently therapeuticallyeffective. The first pulse shape is modified to the second pulse shapeby modifying a slope function of the first pulse shape without modifyingthe overall pulse amplitude by more than 30%, preferably not more than20%, and more preferably not more than 10%. In another embodiment, thefirst pulse shape is modified to the second pulse shape by increasing arate of increase from a minimum pulse amplitude to a maximum pulseamplitude, increasing a rate of decrease from a maximum pulse amplitudeto a minimum pulse amplitude, and/or lengthening a time at which thepulse remains at the maximum pulse amplitude.

For an exemplary test environment, Table W shows a plurality of skinimpedance magnitudes obtained, using a MetroOhm AutoLab PGSTAT128Nelectrochemical workstation, by connecting two electrodes (of anembodiment of the EDP device of the present specification) in serieswith a patient's skin/abdomen impedance. Next, the electrode attached tothe patient's abdomen was connected to a stimulator, of an embodiment ofthe EDP device of the present specification, programmed with asymmetricbiphasic charge balanced waveform. As shown in Table X, using afrequency of 20 Hz and pulse width of 200 μs, the regulated currentoutput was set to various values while the compliance voltage waveformwas obtained on an oscilloscope.

TABLE W Frequency Impedance (kHz) (kohm) 1 5.5 2 3.6 3 2.8 4 2.3 5 2.0 61.7 7 1.6 8 1.5 9 1.3 10 1.2

TABLE X Voltage Current Peak (mA) (V) 5 14 10 26 15 39 20 40 30 40

As seen in Table X, a maximum peak compliance voltage of approximately40 volts was obtained around 16 mA of current. The waveform for the 20mA setting is illustrated as the first waveform 5905 in FIG. 59A.Further increases in nominal current setting did not increase peakvoltage past 40 Volts (since this was the maximum compliance voltage ofthe stimulator used). However, as the nominal current setting wasincreased, the leading voltage edge became steeper yielding a more‘square waveform’ illustrated as the second waveform 5910 in FIG. 59B.This resulted in more charge being applied to the user (that is, areaunder the curve) and/or steeper initial upswing in current waveformminimizing the effects of accommodation—hence increased stimulationsensation to the user.

In some embodiments of the present specification, a flipped waveform isalternated every other pulse to ensure balanced charge while changingthe leading edge time constant (that is, the slope). It should be notedthat the ‘sloping waveform’ 5905 is characterized by a rate of increasefrom a minimum amplitude to a maximum amplitude that is less than thatof the ‘square waveform’ 5910 and/or a rate of decrease from a maximumamplitude to a minimum amplitude that is less than that of the ‘squarewaveform’ 5910. Both waveforms 5905, 5910 have the same peak compliancevoltage but different time constants for the rising phase and hencedifferent stimulation levels perceived by the user. Thus, modifying thewaveform from the first waveform to the second waveform increases thestimulation sensation to the user. In embodiments, the modulation ortitration of the waveform may be affected in response to the user'sinput to the VAS hunger scale. In other words, if the user's VAS hungerscale, using stimulation with the first waveform, shows increased hungeror unchanged yet high hunger level after at least one stimulationsession the stimulation waveform is modified to the second waveformeither automatically (after the user's approval) or manually by theuser. In various embodiments, the slope of the stimulation pulsewaveform is gradually reduced from a substantially ‘sloping’ waveform toa less sloping or substantially ‘square’ waveform. In some embodiments,the waveform is modified from a ‘sloping’ waveform to a less sloping or‘square’ waveform without modifying the pulse amplitude by more than10%.

Placebo Stimulation Protocol for Psychological Treatment

In accordance with some aspects of the present specification, the HMAprograms the EDP device to deliver placebo stimulation to the user inlieu of or in addition to actual stimulation sessions. Placebostimulation refers to creating a perception of stimulation to modulatethe psychology of the user without actually delivering an electricalstimulation treatment. In embodiments, placebo stimulation creates apsychological ‘feeling’ of receiving a stimulation treatment in theuser—leading to a positive therapeutic effect (also referred to as the“placebo effect” or “placebo response”).

In various embodiments, to create a placebo effect, the EDP device maydo any one or a combination of the following: vibrate at an amplitudeand/or frequency perceptible to the user, flash LEDs during a treatmentsession to create a feeling in the user that a therapy session isunderway, generate auditory intonations or sounds, generate verbalmessages to create an impression that a treatment is being delivered.

It should be appreciated that placebo stimulation sessions may beinterleaved with actual electrical stimulation sessions, in variousembodiments.

Incremental or Residual Therapy Benefits (Latency Effect), TherapyVacation and Maintenance Therapy

In accordance with aspects of the present specification, a user'sstimulation therapy program or cycle, delivered using the EDP deviceembodiments of the present specification, comprises a plurality ofphases or stages:

A first therapy phase is a period of time during which the user isdelivered pre-programmed, customized and/or on-demand stimulationsessions. The first therapy phase is characterized by the fact that theuser has a first (baseline) metabolic or health state at the beginningof the first therapy phase and a second metabolic or health state at theend of the first therapy phase. The first metabolic or health state maybe defined by reference to the quantitative value of only one parameterof the patient's metabolic or health state, to the quantitative value ofa subset of all parameters defining the metabolic or health state, or tothe quantitative value of all parameters defining the metabolic orhealth state.

The first therapy phase is an active treatment period that may last fora period ranging from days, weeks to months to achieve the secondmetabolic or health state which is an improved or fully treatedmetabolic or health state compared to the first metabolic or healthstate of the user. In embodiments, achieving the second metabolic orhealth state comprises achieving one or more underlying therapeuticobjectives that define a metabolic or health state such as, but notlimited to, target weight loss and/or target glucose level. Inembodiments, the end of the first therapy phase is marked by the user a)achieving at least one or any sub-set or combination of therapeuticobjectives underlying the user's metabolic or health state (refer to thedefinition of “metabolic or health state” earlier in thisspecification), and/or b) completing a predetermined number ofstimulation sessions (such as, three sessions over three separate days)over a predetermined therapeutic time period (such as, for example, 3 or6 months).

A second therapy phase (that begins at the end of the first therapyphase) is a period of time during which the user is not delivered anystimulation but during which the user still continues to possess orenjoy incremental therapy or residual benefits (also referred to as‘latency effect’) emanating from the treatment of the first therapyphase. In other words, although stimulation sessions are stopped and theuser is on a therapy vacation, the user either continues to stay at thesecond metabolic or health state or the user's second metabolic orhealth state does not deteriorate and change by more than 15% during thesecond therapy phase. That is, the achieved at least one therapeuticobjective (at the end of the first therapy phase) which defines themetabolic state does not degrade by more than 15%. In embodiments, thesecond therapy phase may extend over a period of days, weeks or months.

In some embodiments, the second therapy phase may extend an amount oftime less than, equal to or greater than the first therapy phase ortreatment period without degrading by more than 15%. For example, duringthe first therapy phase if the user is stimulated for a minimum amountof time, e.g. three times over three separate days for at least 15minutes each time at 5 mA per session (or preferably, 30 minutes eachtime at 20 mA per session), then an improvement in a therapeuticobjective such as, but not limited to, delay in gastric emptying (say, a10% delay in gastric emptying post-stimulation therapy relative to thedelay in gastric emptying prior to the stimulation therapy) continuesfor at least one day after terminating the stimulation.

FIG. 60 shows a graph comparing a therapeutic objective, such as % TotalBody Weight Loss (% TBWL), achieved using the EDP devices of the presentspecification for 3 months against the % TBWL achieved using anIntragastric Balloon for 6 months. With reference to FIG. 60, a first %TBWL value 6005 is achieved using an Intragastric Balloon for 6 monthswith a first dietary regimen and a first lifestyle (that is, a certainintensity of exercising—for example), a second % TBWL value 6010 isachieved using the Intragastric Balloon for 6 months with a seconddietary regimen and a second lifestyle, whereas a third % TBWL value6015 is achieved using just the first dietary regimen and lifestyle (andwithout using the Intragastric Balloon).

The first bar graph 6020 illustrates the % TBWL value achieved using afirst stimulation protocol lasting over 3 months and combined with thefirst dietary regimen and the first lifestyle, the second bar graph 6025illustrates the % TBWL value achieved using a second stimulationprotocol lasting over 3 months and combined with the first dietaryregimen and the first lifestyle, whereas the third bar graph 6030illustrates the % TBWL value achieved using the second stimulationprotocol lasting over 3 months and combined with the second dietaryregimen and the second lifestyle. In other words, the % TBWL valuesrepresented by the first, second and third bar graphs 6020, 6025, 6030are achieved at the end of the 3 months period (the first therapyphase).

The fourth bar graph 6035 illustrates the % TBWL value retained at theend of 3 months after terminating stimulation (that is, at the end ofthe second therapy phase) in comparison to the first bar graph 6020 andassociated % TBWL value achieved using the first stimulation protocollasting over 3 months and combined with the first dietary regimen andthe first lifestyle, the fifth bar graph 6040 illustrates the % TBWLvalue retained at the end of 3 months after terminating stimulation(that is, at the end of the second therapy phase) in comparison to thesecond bar graph 6025 and associated % TBWL value achieved using thesecond stimulation protocol lasting over 3 months and combined with thefirst dietary regimen and the first lifestyle, whereas the sixth bargraph 6045 illustrates the % TBWL value retained at the end of 3 monthsafter terminating stimulation (that is, at the end of the second therapyphase) in comparison to the third bar graph 6030 and associated % TBWLvalue achieved using the second stimulation protocol lasting over 3months and combined with the second dietary regimen and the secondlifestyle.

As can be observed from FIG. 60, a) 70 to 90% of % TBWL value achievedduring the first therapy phase was extended or retained during thesecond therapy phase, and b) the % TBWL values achieved usingstimulation therapy was comparable to corresponding % TBWL valuesachieved using an Intragastric Balloon.

In various embodiments, an end of the second therapy phase is marked bythe user's metabolic or health state returning to a third metabolic orhealth state wherein the third metabolic or health state is lower thanthe second metabolic or health state by more than 15%. In someembodiments, however, the third metabolic or health state may beequivalent to the user's first or baseline metabolic or health state.

Accordingly, in one embodiment, after a first phase of treatment usingone of the aforementioned stimulation protocols, wherein the first phaselasts anywhere from 1 to 6 months, preferably 3, the patient loses apercent of total body weight in a range of 3% to 15%, preferably between6% and 10%. After stimulation ceases and a second phase of time elapses(such as between 1 and 6 months, preferably 3), the percent of totalbody weight lost is in a range of 2% to 14%, preferably between 5% and9%.

A third therapy phase (that begins at the end of the second therapyphase) is a period of time during which stimulation treatment isrecommenced for the user as part of a maintenance therapy. An objectiveof the maintenance therapy is to ensure that the user either continuesto stay or maintain the second metabolic or health state (if the userwas at the second metabolic or health state at the end of the secondtherapy phase) or re-achieve and thereafter maintain the secondmetabolic or health state (if the user had fallen to the third metabolicor health state at the end of the second therapy phase). The maintenancetherapy is characterized by a stimulation protocol that delivers a lowerlevel of stimulation energy or intensity (such as, for example, fewernumber of stimulation sessions per week and/or stimulation sessions atlower amplitudes) throughout the third therapy phase as compared to thelevel of stimulation energy or intensity delivered to the user duringthe first therapy phase. In embodiments, the third therapy phase mayextend over a period of weeks or months.

It should be appreciated that the EDP based methods and systems of thepresent specification enable stimulation therapy to be delivered to thepatient over extended period of time (ranging from weeks to months) withexceptionally high patient compliance to the therapy regimen while atthe same time effectively avoiding and managing undesired affects suchas habituation, nausea and/or dyspepsia. Owing to high therapycompliance over an extended therapy period, the patient's metabolic orhealth state is continuously reset to a better state throughout thefirst therapy phase—leading eventually to the second metabolic or healthstate. As a result, even when stimulation is stopped at the end of thefirst therapy phase, the patient continues to benefit therapeutically,during the second therapy phase, from the second metabolic or healthstate achieved due to a cumulative or latency effect (or a‘neurostimulation durability effect’) of the stimulation therapy.Accordingly, the patient is enabled to take a vacation from therapy,during the second therapy phase, allowing the patient to further rid herbody of any tendency to habituation to the stimulation while also takinga break from the daily routine of therapy.

Following the therapy vacation, that is during the third therapy phase,stimulation is recommenced but at lower levels of delivered energy inorder to maintain the metabolic reset without risk of habituation. Invarious embodiments, over long term, maintenance therapy would proceedvia a combination of therapy vacations and maintenance stimulation (at alower level of stimulation intensity or energy). Inputs to long termmaintenance therapy would be from continuing patient diary (such as, butnot limited to, daily weight, hunger, well-being).

In accordance with aspects of the present specification, the stimulationtherapy program or cycle comprising the first, second and third therapyphases is managed, controlled and effectuated by the HMA via reminders,prompts and stimulation sessions in combination with subscriptionbilling options. For example, in some embodiments, once at least onetherapeutic goal, such as weight loss, has been achieved or a certainpredetermined number of stimulation sessions have been completed over apredetermined therapeutic time period (for example, 3 to 6 months), theHMA a) automatically discontinues stimulation (in the second therapyphase) to allow the patient's body to rid of habituation effects, and b)requires the user to pay a renewal fee (perhaps lower than the feerequired during the first therapy phase) to initiate maintenance therapy(in the third therapy phase).

Methods of Use

In accordance with various aspects of the present specification, theuser is enabled to apply or use the electro-dermal patch device of thepresent specification with active, regular, periodic, none and/orminimal intervention, monitoring and management from a physician,dietician, weight loss clinician or a remote patient care facility(hereinafter referred to as a TPM (Third Party Manager) who will beresponsible for prescribing the EDP device and monitoring therapy.

In some embodiments, the user visits his physician for just one sessionwherein, depending upon the user's medical condition, the physician mayprescribe the electro-dermal patch device of the present specificationto the user along with the stimulation configuration, from the externalsurface of the patient's epidermal layer through 10 mm or 20 mm of thedermis, of the electro-dermal patch device, as described with referenceto FIG. 1A through 1C. In some embodiments, the user visits a TPM for amedical check-up or evaluation wherein, depending upon the user'smedical condition, the TPM may prescribe the electro-dermal patch deviceof the present specification to the user along with the stimulationconfiguration, from the external surface of the patient's epidermallayer through 10 mm or 20 mm of the dermis, of the electro-dermal patchdevice, as described with reference to FIG. 1A through 1C.

In various embodiments, a stimulation depth through the patient'sepidermal layer ranges from 0.1 mm to 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9,10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 mm or any increment therein.

In some embodiments, the user's need for the EDP device therapy isdetermined based on, at least, his current BMI for appetite modulation.For example, the EDP device therapy is recommended if the current BMI ofthe user lies above a BMI threshold ranging from 20 to 25, preferablygreater than or equal to 25. Alternatively or additionally, the TPM mayutilize the user's SNAQ score, for example, to assess if the user isanorexic or has poor appetite. If so, the TPM may not recommend EDPdevice therapy for the user. Similarly, if the user's BMI is below 20then the EDP device therapy may not be considered ideal for the user. Inother words, the TPM evaluates the user's medical condition to make surethat the user would benefit from the stimulation therapy and not beharmed.

During the session, the physician or the TPM then assists or instructsthe user in identifying appropriate areas of stimulation, such as T6, C8and/or T1 dermatomes for conditions of obesity, over-weight, eatingdisorders, metabolic syndrome and T7 for T2DM management, and alsoprovides an orientation to the user regarding use and functions of theelectro-dermal patch device. In various embodiments, the appropriateareas of stimulation may be identified, for example, by one or moretemporary tattoos (such as a small dot) or an image of the user may betaken with a mark or icon locating the appropriate area on the user'sbody. FIG. 17D is a flow chart listing the steps involved in one methodof identifying a proper placement location for an electro-dermal patchon a front thoracic surface of a user, in accordance with one embodimentof the present specification. At step 1732, with the user preferablystanding, the TPM finds a midclavicular line of the user. The TPM thenprogresses downward from the midclavicular line to a bottom rib of athoracic cage of the user at step 1734. From the bottom rib, at step1736, the TPM moves downward by 2 cm to identify a placement spot. Atstep 1738, the TPM places a top center portion of the electro-dermalpatch at the placement spot.

During the session, the physician or the TPM may further help the userto download the Health Management application on the user's computingdevice, such as his smartphone, tablet, PDA, laptop, computer anddemonstrate pairing or syncing of the application to the user'scomputing device. The user may at this time or at a later time enablethe Health Management application to be in communication with thephysician or a remote patient care facility.

In alternate embodiments, the physician's or the TPM's intervention forinitial set-up and use orientation of the electro-dermal patch devicemay not be required at all. In such embodiments, the user simply buysthe electro-dermal patch device that comes along with a compact diskcomprising detailed audio-visual tutorials demonstrating use,application download instructions, functions and identification ofappropriate areas of stimulation. Additionally or alternatively, theaudio-visual tutorials may be made accessible to the user via adedicated website also hosting a web version of the Health Managementapplication.

In some embodiments, the HMA also includes a device placementfunctionality to enable identification of the appropriate location onthe user for placement of the EDP device. In one embodiment, where theHMA is installed on the user's smartphone (configured as the companiondevice), the device placement functionality operates by overlaying animage of where the identification mark or icon should be on the body ofthe user while the user's torso is being imaged by the user'ssmartphone. Thus, when the TPM activates the device placementfunctionality (such as by activating an icon on the user's smartphone),the TPM is instructed to stand at a pre-defined distance, such as 20inches, from the user's torso and view the user's torso image byactivating the camera of the smartphone. With the torso in view, overlaya mark, icon or dot on the image. The device placement functionalitycaptures and stores the image with the overlay and the TPM then uses itto place a temporary tattoo on the user. When the device placementfunctionality or feature is activated again, the location of the tattoocan be compared with the overlay. Each time placement of the EDP deviceneeds to be reviewed, the device placement functionality isactivated—which will display the stored image with the overlay,preferably with the overlay relative to an outline of the nipple andbelly button.

The HMA also enables the TPM to be associated with the user's EDP. Toenable this association, in some embodiments, the TPM is presented witha GUI wherein the TPM inputs, for example, his unique code thatassociates the user, and therefore the user's EDP device, with the TPM.The TPM next pairs or syncs the user's computing device with the user'sEDP device. Associating or linking the TPM and the user enables aplurality of functions such as, but not limited to, allowing the TPM toregularly receive and access, in real time or near real time, the user'shealth related information and progress reports related to varioustherapeutic objectives, to accordingly modulate or titrate stimulationprotocols and parameters when needed; and enabling the TPM to deactivateand reactivate the EDP device remotely, when needed.

The TPM now configures, sets up or programs the stimulation protocolsand parameters for therapy. In accordance with various embodiments, theTPM configures the stimulation therapy to be set at the standard orbaseline stimulation protocol, in absence of any initial health relateddata of the user. As discussed earlier, in one embodiment the standardor baseline stimulation protocol (also referred to as ‘defaultoperational mode’) is set at 3 daily stimulation sessions of 30 minuteseach having a pulse amplitude of 20 mA. Each of the three dailystimulation sessions is initiated 30 to 60 minutes and preferably 45minutes prior to mealtimes, such as, breakfast, lunch and dinner, forexample. As the therapy progresses, the TPM periodically adjusts thebaseline stimulation protocol or pattern based on the user's healthrelated information and recommendations from the HMA.

In another preferred embodiment, the baseline stimulation scheme orprotocol is set at 3 daily stimulation sessions of 15 minutes eachhaving a pulse amplitude of 20 mA timed pre-prandial and 60 minutes eachhaving a pulse amplitude of 20 mA timed post-prandial, that isimmediately prior to commencement and upon completion of each meal suchas breakfast, lunch and dinner. In other words, the baseline stimulationscheme or protocol comprises 3×1.25 hours=3.75 hours total (15 minutespre-prandial to each meal and 60 minutes post prandial). In someembodiments, the base line pulse amplitude ranges from 5 mA to 10 mA toenable total stimulation durations that are longer than 3.75 hours. Invarious embodiments, these post-prandial stimulation sessions aretriggered manually by the user. In some alternate embodiments, thepre-prandial and post-prandial stimulation sessions are automaticallytriggered based on pre-stored meal time schedule. In some alternateembodiments, the post-prandial stimulation sessions are automaticallytriggered with reference to a detection of an eating event by a swallowdetection device, such as the device 5605 of FIG. 56, or by the eatingmoment recognition method (FIG. 58) implemented by the HMA using aplurality of data (representing the user's food intake gestures)captured by an accelerometer, wherein the accelerometer is included in awrist-band or wristwatch, such as the band 2105 of FIG. 21A or thewristwatch 2106 of FIG. 21B.

The TPM also configures rescue protocols and parameters for allowablerescue sessions. The configurable rescue protocols and parametersinclude at least the number of rescue sessions allowed per day,duration, and intensity of stimulation. The TPM may also program rescuesessions based on triggers such as, but not limited to, the user'senergy balance. For example, if the user's energy balance is positiveand above a predefined threshold, one or more rescue sessions aretriggered to occur in addition to the standard stimulation therapy orschedule.

In accordance with various embodiments, the TPM may alternatively oradditionally program the stimulation protocols and parameters byallocating a total energy budget to the planned or scheduled therapysessions (such as those part of the standard or baseline stimulationprotocol) and to the rescue sessions (that is, unplanned on-demandsessions). In various embodiments, the total energy budget can beapportioned between the planned therapy sessions and the rescuesessions, subject to the daily total rescue budget (described earlier inthe specification). In various embodiments, the total energy budget ismeasured in Joules. The TPM is allowed to distribute the allocated totalenergy budget over a period of time. In other words, the TPM programsthe stimulation therapy by subjecting the user to a total amount ofenergy (in the form of stimulations) that is distributed over a periodof time of therapy. The TPM has flexibility to program or distribute theallocated energy budget in any manner suitable for the user such as, forexample, 40 mA stimulation for 23 hours or stimulation of 10 mA per dayfor 30 minutes a day. In accordance with various aspects, the TPM'sflexibility to distribute the allocated total energy budget over aperiod of time is subject to the following constraints:

-   -   The user must necessarily receive a certain amount (also        referred to as ‘energy input’) of the allocated total energy        budget, per week. In various embodiments, a minimum energy input        per week is 1 minute of 5 mA stimulation once per week and a        maximum energy input per week constitutes 50 mA constant        stimulation over 24 hour period. Thus, for an overall therapy        cycle of 6 months or 180 days, the maximum energy input is 50        mA×24 hr per day×180 days.    -   The amount of energy delivered to the user in an allowed rescue        session should not be greater than two times the amount of        energy of a planned therapy session (such as a session of the        standard or baseline stimulation protocol). In some embodiments,        the amount of energy of an allowed rescue session should range        from 5% to 200% of the amount of energy of a planned therapy        session.    -   Preferably, a rescue session and a planned therapy session are        separated by a predefined period of off-time. In some        embodiments, the predefined period of off-time is defined such        that for every Z minutes of stimulation in a session (rescue or        planned therapy), at least 10%×Z minutes of off-time (that is,        no stimulation) is necessary.    -   A rescue session and a planned therapy session, if occurring        serially, should not result in an excessive amount of total        energy input into the user that causes a breach of the allocated        total energy budget for the entire therapy cycle. Thus, for        example, if the user demands a rescue session just before a        planned therapy session, the HMA is programmed or configured to        choose between a) replacing the demanded rescue session with the        scheduled or planned therapy session, that is the demanded        rescue session is not allowed while continuing with the planned        therapy session as scheduled, b) initiating the demanded rescue        session and then moving onto the planned therapy session but        truncating the planned session, if needed, to ensure that the        allocated total energy budget for the entire therapy cycle is        not breached or exceeded. If a rescue session overlaps with a        planned therapy session then the planned therapy session is        moved forward so that the two sessions are separated by at least        the predefined period of off-time. Similarly, if a rescue        session does not overlap with a planned therapy session, the        rescue session may be allowed provided the sessions (rescue and        planned) are separated by at least the predefined period of        off-time. In all cases, however, the total energy input into the        user is not allowed to exceed the allocated total energy budget.

Once the TPM completes programming or configuration of the stimulationprotocols and parameters, the HMA acknowledges that the configuration issuccessful and the EDP device also acknowledges successful configurationby, for example, vibratory, auditory and/or visual indications (such asflashing LEDs of a specific color). In some embodiments, the TPM mayalso prescribe a low calorie planned diet for the user. In variousembodiments, a first planned therapy session is delivered to the user atthe TPM's office or clinic to ensure that the stimulation parameters areconducive to the user. For example, a 30 or 60 minute session atbaseline stimulation protocol is delivered to the user. If the userfeels fine after the first session, the user is allowed to leave tocontinue the therapy at home. However, if the user reports inconvenienceor deterioration in well-being, such as due to a feeling of nausea, theTPM reprograms the stimulation protocols and parameters by, for example,ramping down the intensity, duration, number of stimulation sessions perday and/or the total energy budget.

The user continues the TPM configured stimulation therapy at home. Athome, the user may take off the EDP device for some time and may forgetto put the EDP device on for his next planned therapy session. Animpedance or bio-impedance sensor of the EDP device is used to detectand confirm contact integrity of the EDP device electrodes with tissuesto be stimulated and therefore detect if the EDP device is being worn bythe user. In some embodiments, if the impedance or bio-impedancemeasurement detects that the user is not wearing the EDP device, the EDPdevice and/or the companion device implementing the HMA, such as asmartphone, smart watch or smart band, generates vibratory, auditoryand/or visual (such as flashing LEDs) alerts that are repeated atperiodic intervals till the user wears the EDP device. When the EDPdevice has been worn by the user, as indicated by the impedancemeasurement, it is also determined if the user is or is not exposed towater such as, for example, during shower, while swimming or whiletraveling in rain. At least one of impedance, humidity and temperaturesensor, included in the EDP device, is utilized to determine if theperson and/or the EDP device is exposed to water. If the user and/or theEDP device are exposed to water, the EDP device is automaticallyswitched off and all stimulation held off.

In accordance with an embodiment, the HMA generates vibratory, auditoryand/or visual (such as flashing LEDs) alert or reminder, using the EDPdevice and/or the companion device (such as a smartphone, smart watch orsmart band), at least 60 minutes prior to a scheduled stimulationsession. This advance reminder allows the user requisite time to get tothe EDP device and wear it—in case the EDP device was taken off by theuser. Thus, in some embodiments, the alert or reminder is linked to theuser's schedule of stimulation sessions and is programmed to remind theuser, a requisite time (say, 60 minutes) ahead of a scheduled session,to ensure that the user wears her EDP device in time. Accordingly, inone embodiment, the smartphone comprises a plurality of programmaticinstructions that automatically set an alarm for a predefined period oftime, such as 120 minutes to 5 minutes and any increment therein, beforethe scheduled stimulation session. The alarm, which could be visual,auditory, and/or vibratory and which could be delivered via thesmartphone or the EDP itself, communicates to the patient the need toput on the EDP in order to effectuate a stimulation session.

However, it is possible that the user's first stimulation session of theday is scheduled later than breakfast time, in which case the remindermay alert the patient after she has left for work that day (perhapsleaving the EDP device behind at home). To address such a scenario, insome embodiments, the first alert or reminder of the day is linked tothe user's break-of-day that is programmed according to the user'swaking-up schedule. For example, in an embodiment, the first alert orreminder of the day is linked to the user's alarm clock on hersmartphone (companion device) to trigger a reminder (to wear the EDPdevice) within 0 to 60 minutes of the user's wake-up alarm going off.Thus, in some embodiments, while the first alert or reminder of the dayis linked to the user's waking-up schedule, the remaining alerts orreminders of the day are linked to the user's schedule of stimulationsessions.

In accordance with another aspect, the EDP device is programmed to alertthe user before commencing a stimulation session. In some embodiments,for example, the EDP device generates a low intensity stimulation orvibration, as preparatory signal to alert the user, before applying fulltherapy stimulation. This prevents the user from being surprised by asudden onset of stimulation. In accordance with yet another aspect, theEDP device is switched off or deactivated if it senses an increase inthe user's skin temperature above a threshold temperature within apredetermined period of time, thereby safeguarding the user from skinburns.

As the user continues to use the EDP device at home, the stimulationparameters and protocols, for both planned as well as rescue sessions,are modulated based on a plurality of health related information of theuser generated as a result of the use of the EDP device. In accordancewith an aspect, the TPM monitors the user's health related informationand may periodically intervene by re-setting or reprogramming the EDPdevice and HMA. Thus, while the HMA is configured to automaticallymodulate or titrate stimulation based on the user's health relatedinformation, well-being scores and/or rescue sessions, in variousembodiments the TPM may, remotely, at any time supersede and reprogramthe HMA (with or without the user's consent). Additionally, inaccordance with some aspects, the TPM's unique code allows the user toapply the stimulation therapy for only a predefined period of time, suchas ranging from a few days to four weeks. At the end of the predefinedperiod of time, the HMA may switch off the EDP device and therefore thetherapy and prompt the user to contact his TPM for evaluation,modulation of the stimulation protocol and parameters (if needed),feedback and/or counseling before restarting the therapy.

In accordance with various embodiments, as discussed earlier in thisspecification, all time-stamped hunger entries or events (whetherplanned or unplanned), intensity levels and the triggered rescuesessions are tracked (date and time stamped, including duration of eachrescue session) and recorded (such as through the light bar VAS) togenerate the user's individualized hunger profile or hunger map. In someembodiments, the user's individualized hunger map is in the form of ascattergram or heat map. The scattergram maps and displays a pluralityof icons or dots of different colors wherein each dot corresponds to ahunger event and the color of the dot represents the level of intensityof hunger recorded corresponding to the hunger event. If the rescuesessions or dots represent a pattern of hunger or hunger spikes, such asfor example if a large number of high intensity hunger dots congregateat a particular time of day for a certain period of time (ranging from afew days, say 5 to 7 days, to weeks, say 3 to 6 weeks), the HMA and/orthe TPM may customize, modify, drive and deliver stimulation therapy orprotocol to target the user's hunger spikes.

In accordance with various embodiments, the TPM programs the HMA for asurvey to be presented to and filled in by the user each day throughoutthe period of the therapy. The TPM programs the HMA to present thesurvey to the user depending upon the user's preferred or desiredtimings or time window during the day. For example, the user may desirethe survey to be presented to him within a time window between 5 pm andmidnight each day. Accordingly, the HMA notifies and presents the userwith the survey within the desired time window. The user can take thesurvey or put the survey off for a later time. The user can also demandthe survey at any time (outside the desired time window). In variousembodiments, the survey enables the user to summarize, input and recordhealth related information comprising at least his level of hunger,appetite, exercise, and well-being for the day. The scores representinglevels of appetite, exercise, hunger, and well-being are recorded viarespective light bar VAS or through the GUI screens of FIGS. 11, 12, 13and 16 respectively. The user is also allowed to input and record thetotal calories consumed for the day. It should be appreciated that thesurvey ensures that the user is persuaded to regularly provide datarelated to, at least, his levels of hunger, appetite, exercise,well-being and calories consumed.

Thus, the survey acts as a safeguard against scenarios where the usermay not be self-motivated to regularly record his health relatedinformation. In fact, it is possible that the user may not feel the needfor rescue sessions and may not use up any of his daily total rescuebudget. In such events, it will also not be possible to generate theuser's individualized hunger map and determine stimulation modulation astherapy progresses. The necessity of recording hunger level, within thesurvey, safeguards against such scenarios where no rescue sessions aredemanded by the user.

In accordance with various aspects, the HMA ensures that the userresponds to the survey. Therefore, in some embodiments if the user doesnot respond to the survey he is continuously, repeatedly or periodicallyalerted to fill in the survey. The alerts may be vibratory, auditoryand/or visual (such as flashing LEDs) generated by the EDP device and/orthe user's smartphone (acting as a companion device). In someembodiments, the user is allowed to resolve the alerts only byresponding to the survey. In some embodiments, if the user does notrespond to the survey for a predefined period of time, such as 1, 2, 3,4, 5, 6 or 7 or any number of days or increment therein, the EDP deviceis switched off or deactivated or the TPM can deactivate the EDP deviceremotely and is reactivated only by the TPM. The TPM can reset orreactivate the EDP device remotely, such as by remotely inputting orproviding the user with a reactivation code, based on a conversationwith the user.

It should be appreciated that the TPM's ability to remotely deactivateand reactivate the EDP device is also advantageous in scenarios wherethe user's recorded health related information (through the survey)indicates that the user is likely to suffer some harm (if the therapy iscontinued in its present state) such as, but not limited to, loss of toomuch weight, high levels of nausea that is recurring frequently.

The TPM is also allowed, by the HMA, to set or reconfigure variousthresholds, ranges, protocols and parameters related to planned therapysessions and rescue sessions as and when needed such as, during theinitial set-up of the EDP device and/or during therapy based on theinformation provided by the user through the survey or based on theuser's individualized hunger and/or well-being maps or profiles. Forexample, the TPM may configure and re-configure the thresholds fordeciding when an unplanned hunger event is considered actionable andwhen a nausea and/or dyspepsia event is considered actionable. The TPMmay also configure and re-configure as to what happens when actionableunplanned hunger and nausea (and/or dyspepsia) events occur. Thus, theTPM may program the HMA to ramp down stimulation if the user records asingle nausea and/or dyspepsia event of intensity 9 followed by acertain number (say 2 to 3) of less nauseating events of intensity 6 or7. The TPM may also program the HMA to ramp down stimulation to counterhabituation or fatigue. Therefore, after a predefined period of time(say, 3 to 12 weeks—configurable by the TPM), the HMA may be configuredto initiate an anti-habituation temporary ramp down (via, say, reductionof amplitude, frequency and/or duration of sessions). Alternatively, theTPM may configure the HMA to stop stimulation therapy for some time andrestart thereafter.

Since the TPM is associated with the user's EDP device, through theunique code input by the TPM during initial setup or configuration ofthe EDP device for the user, the TPM receives the user's health relatedinformation regularly or periodically—that is daily, weekly or at anyother periodicity customizable by the TPM. In various embodiments, theuser's health related information may be sent and stored in a Cloudbased datacenter and the TPM be notified or the information may be sentdirectly to the TPM. The user's health related information includes, atleast, the user's weight, scores related to appetite, hunger, exercise,well-being (well-being profile including recorded nausea and/ordyspepsia events), values related to calories consumed, andindividualized hunger profile (as a result of recorded unplanned hungerevents and delivered rescue sessions). In some embodiments, the TPMadditionally or alternatively receives a composite score related to andderived from any one or any combination of the user's health relatedinformation. In various embodiments, the TPM has the HMA installed onhis smartphone and/or has an access to a web version of the HMA to beable to monitor the user and receive health related information. The HMAversion installed on the TPM's smartphone, in various embodiments, isenabled for association and therefore data communication with aplurality of users.

In accordance with various aspects of the present specification, the TPMmay intervene at various stages or phases of the therapy depending onthe user's health related information, trends and/or the user's progressin context of the therapeutic objectives or end-points set to beachieved through the therapy. For example, if the user achieves atherapeutic objective, the TPM could extend the therapy (for example, ifthe user loses 10 pounds as per weight loss objective, the TPM mayrecommend continued therapy to lose another 10 pounds), end therapyaltogether, extend a new therapy such as for weight maintenance. The newtherapy may use a different stimulation protocol or may be the same asearlier but with a higher caloric diet, for example.

FIG. 52 is a flow chart illustrating a plurality of steps of a methodfor enabling a TPM to prescribe, configure, manage, monitor andintervene an EDP device based stimulation therapy for a user, inaccordance with some embodiments. At step 5202, a user visits his TPMfor a medical check-up or evaluation. The TPM recommends an EDP deviceof the present specification to the user based on the user's medicalcondition, such as for example obesity or over-weight. At step 5204, theTPM downloads the HMA on the user's smartphone (that works as acompanion device). Thereafter, at step 5206, the TPM assists the user inidentifying appropriate areas of stimulation (and therefore, placementof the EDP device on the user's body), such as T6, C8 and/or T1dermatomes for conditions of obesity, over-weight, eating disorders,metabolic syndrome and T7 for T2DM management, and also provides anorientation to the user regarding use and functions of theelectro-dermal patch device. The EDP device is positioned on theidentified location on the user's body. Next, at step 5208, the TPMassociates or links himself to the user, the user's EDP device and HMA,such as, by inputting his unique code into the user's HMA. Associatingor linking the TPM and the user enables a plurality of functions suchas, but not limited to, allowing the TPM to regularly receive andaccess, in real time or near real time, the user's health relatedinformation and progress reports related to various therapeuticobjectives, to accordingly modulate or titrate stimulation protocols andparameters when needed; and enabling the TPM to deactivate andreactivate the EDP device remotely, when needed.

The TPM pairs or syncs the user's smartphone with the user's EDP device,at step 5210. Thereafter, at step 5212, the TPM configures or programsthe stimulation protocols and parameters, including various associatedthresholds, ranges, related to planned therapy sessions as well asunplanned on-demand rescue sessions. In one embodiment, the TPMconfigures the planned stimulation therapy to be set at standard orbaseline stimulation protocol, in absence of any initial health relatedinformation of the user. At step 5214, the TPM also programs the user'sHMA to generate and present to the user—a survey to illicit the user'shealth related information. The survey is programed to be presented tothe user, daily, within a time window preferred by the user. The TPMmay, optionally, also prescribe a low calorie planned diet for the user.The HMA, at step 5216, acknowledges that the configuration (by the TPM)is successful and the EDP device also acknowledges successfulconfiguration by, for example, vibratory, auditory and/or visualindications or signals (such as flashing LEDs of a specific color).

At step 5218, the TPM delivers a first planned therapy session to theuser in the presence of the TPM to ensure that the HMA or therapyconfiguration is conducive to the user. If the user feels fine after thefirst session, the user is allowed to leave to continue the therapy athome, at step 5220. However, if the user reports inconvenience ordeterioration in well-being, such as due to a feeling of nausea, the TPMreprograms the stimulation protocols and parameters at step 5222. Athome, the user continues with the stimulation therapy, at step 5224, andgenerates a plurality of health related information (such as, but notlimited to, the user's weight, scores related to appetite, hunger,exercise, well-being (well-being profile including recorded nauseaand/or dyspepsia events), values related to calories consumed, andindividualized hunger profile (as a result of recorded unplanned hungerevents and delivered rescue sessions)) during therapy. If and whenneeded, at step 5226, the TPM modulates the stimulation parameters andprotocols, for both planned as well as rescue sessions, based on theplurality of user's health related information while the user iscontinuing with the stimulation therapy at home. The TPM alsointervenes, by re-setting or reprogramming the EDP device and HMA and/ordeactivating and reactivating the EDP device, when needed.

At step 5228, the user's stimulation is stopped, paused and/or the userprompted to revisit his TPM for re-evaluation of his medical conditionor progress.

In accordance with some aspects of the present specification, a user hasa plurality of options for purchasing the EDP device along with theTPM's services. In one embodiment, the user avails of the TPM's serviceat a first fee and purchases the EDP device for a first price. In someembodiments, the first fee and the first price are fixed one-time valuesvalid for an entire treatment cycle of the user. In other embodiments,the user is allowed to pay a single one-time fixed price for a bundleddeal comprising of the TPM's service and the EDP device price. In stillother embodiments, the user purchases a bundled deal, comprising of theTPM's service and the EDP device price, at a price that is valid for apredefined period of time, say, for 1 week to 3 months, and recurs afterthe predefined period of time. In yet other embodiments, the first priceis a one-time payable value while the first fee is valid for apredefined period of time, say, for 1 week to 3 months, and recurs afterthe predefined period of time. In accordance with an aspect, the TPM'sfee schedule is enforced through his unique code that is valid only forthe predefined period of time. For example, if the TPM's first fee isvalid for a month of therapy, the TPM's unique code (input into theuser's HMA) causes the HMA to deactivate the EDP device at the end ofthe month and prompts the user to meet the TPM. Based on the user'smedical condition, the TPM may extend the therapy for another month(using another unique code) for an additional fee. The extended therapymay commence immediately or may restart after putting the user onhiatus. In still other embodiments, while the EDP device can bepurchased for a one-time price, the TPM's fee is linked to achieving ofspecified goals. For example, the TPM's first fee includes an initialEDP therapy set-up and subsequent fees is due after the user achieves aweight loss goal of, say, 10 pounds. In other words, the TPM's fee islinked to the user achieving one or more therapeutic goals within aperiod of time.

In various embodiments, therapy provided by the electro-dermal patch(EDP) devices of the present specification is driven or triggered by aplurality of variables. These variables can be entered by the patient ora medical professional into the companion device, sensed by a sensor onthe EDP, transmitted to the companion device or EDP by a separatedevice, for example, a device, with physiological sensors, configured tobe worn on the human body, such as around the wrist, in order tomonitor, acquire, record, and/or transmit the physiological data, or canbe acquired by a combination of any of the above means. In variousembodiments, the variables are stored, preset, and/or measured or inputon a regular, predetermined basis or time period. In some embodiments,the variables include primary variables which comprise primary driversto any therapy regimen and secondary variables which comprise secondaryindicators which may or may not affect the regimen. Some variables, suchas weight in pounds, are entered into the patient diary based on theiractual value while other variables, such as hunger, appetite andsatiety, are given a score based on a predefined score value range or ascale such as the Visual Analogue Scale (VAS). The treatment algorithmof the companion device analyzes these scores in comparison topredefined limits and automatically modifies therapy accordingly. Insome embodiments, the algorithm analyzes these scores on a daily basis.In other embodiments, the algorithm analyzes the scores every other day,every third day, every fourth day, every fifth day, every sixth day, oronce per week. In various embodiments, the score values range from 0 to100. In a preferred embodiment, the score values range from 1 to 10 and,more preferably, from 1 to 5 or 1 to 3, depending on the variable. Insome embodiments, a high numerical score value indicates electricalstimulation therapy provided by the EDP is inadequate and additionalstimulation is needed. A lower numerical score value indicateselectrical stimulation therapy provided by the EDP is excessive andstimulation needs to be reduced. Conversely, in other embodiments, ahigh numerical score value indicates stimulation is excessive and needsto be reduced and a low numerical score value indicates stimulation isinadequate and needs to be increased. In some embodiments, a numericalscore value proximate the middle of the score range indicates therapy isappropriate and can remain unchanged.

In one embodiment, the system uses one or more of the following triggersto initiate stimulation or modulate stimulation settings: a patient'sglycemic level, metabolism levels, hemoglobin A1c, and/or blood sugar.Using integral physiological sensors or third party external deviceswhich already measure metabolism, blood sugar, glycemic levels, orhemoglobin A1c, the companion device gathers such data, integrates itwith existing patient status data, and generates a modulated stimulationsetting, which may include a signal to initiate therapy, change therapyor cease therapy, based on an integrated patient status data profile. Inone embodiment, a patient's increased blood sugar levels cause thestimulation settings to be modulated upward in order to increase therate, frequency, or overall amount of stimulation. In one embodiment, apatient's decreased or normalized blood sugar levels (as a result of adelivered stimulation therapy, for example) cause the stimulationsettings to be modulated downward in order to decrease the rate,frequency, or overall amount of stimulation. In one embodiment, apatient's decreased or normalized blood sugar levels (as a result of adelivered stimulation therapy, for example) cause the stimulationtherapy to be ceased. In another embodiment, changes in the patientstatus data, including increases or decreases in metabolism, bloodsugar, glycemic levels, or hemoglobin A1c, may cause the companiondevice to recommend moving the EDP to a different location on thepatient's body to stimulate a different dermatome, such as from C8 onthe hand to T1 or, for example, from T7 in the abdominal area to T6.

In some embodiments, therapy is driven by a set of three primarydrivers. The primary drivers include: hunger, which is defined as thepatient's desire to eat; appetite, defined as how much food the patienteats in relation to a diet plan (also considered caloric intake); andwell-being, defined as simply how good the patient feels. In someembodiments, well-being is further subdivided specifically into feelingsof nausea, dyspepsia, discomfort, energy level, and weakness/strength.Each of these primary drivers can be attributed a score which is enteredinto the companion device, as depicted in FIGS. 11, 13, and 16.

For example, for hunger, referring to FIG. 13, the patient can enter ahunger score from 1 to 5, wherein 1 indicates the patient is not hungryat all, 2 indicates the patient is almost never hungry, 3 indicates thepatient is not particularly hungry, 4 indicates the patient isfrequently hungry, and 5 indicates the patient is extremely hungry mostof the time. In some embodiments, a hunger score having a highernumerical value indicates appetite suppression is inadequate and thepatient requires greater stimulation. The treatment algorithm of thecompanion device recognizes the need for greater stimulation asindicated by the higher score and titrates therapy accordingly. Forexample, in one embodiment, if the patient enters a hunger score greaterthan 3 in the patient diary over a period of four to seven consecutivedays within the first week, the algorithm uses the score toincrementally increase the duration of each stimulation session. Ifafter three weeks the patient enters a hunger score greater than 3 inthe patient diary for 3 consecutive days, the algorithm uses the scoreto increase the number of stimulation sessions per day. Conversely, alower hunger score indicates stimulation needs to be decreased. Forexample, if the patient enters a hunger score of 1 for three consecutivedays within the first week, stimulation sessions are decreased induration and frequency. In other embodiments, the hunger score scaleextends from 1 to 10.

In other embodiments, rather than a scale to determine the presence orabsence of hunger, the system presents the patient with a scaleconfigured to record changes in his hunger after stimulation. Forexample, in an embodiment, a hunger change score scale extends from 1 to3 wherein 1 is indicative of no change, 2 is indicative of some change,and 3 is indicative of significant change in hunger after stimulation.If a patient reports a 1, no change in hunger after stimulation,stimulation parameters are increased.

For appetite, referring to FIG. 11, the patient can enter an appetitescore from 1 to 5, wherein 1 indicates the patient ate substantiallyless than his diet, 2 indicates the patient ate a little less than hisdiet, 3 indicates the patient followed his diet, 4 indicates the patientsomewhat exceeded his diet, and 5 indicates the patient substantiallyexceeded his diet. As with the hunger score discussed above, in someembodiments, an appetite score having a higher numerical value indicatesappetite suppression is inadequate and the patient requires greaterstimulation. The treatment algorithm of the companion device recognizesthe need for greater stimulation as indicated by the higher score andtitrates therapy accordingly. For example, in one embodiment, if thepatient enters an appetite score greater than 3 in the patient diaryover a period of four to seven consecutive days within the first week,the algorithm uses the score to incrementally increase the duration ofeach stimulation session. If after three weeks the patient enters anappetite score greater than 3 in the patient diary for 3 consecutivedays, the algorithm uses the score to increase the number of stimulationsessions per day. Conversely, a lower appetite score indicatesstimulation needs to be decreased. For example, if the patient enters anappetite score of 1 for three consecutive days within the first week,stimulation sessions are decreased in duration and frequency. In otherembodiments, the appetite scale extends from 1 to 10.

As discussed earlier, in some embodiments the plurality of variables,such as hunger, appetite, satiation level, fullness, satiety, andfeelings of pain, nausea, or dyspepsia, that drive or trigger therapyare alternately assessed on at least one of a plurality of scientificVAS scales. Graphs 36A through 38F represent exemplary data which theinventors believe are indicative of the therapeutic benefits of thepresent inventions. It should be appreciated that data may be collectedand compared on a per patient basis, both before and after stimulation,on a sample group of patients, both before and after stimulation, or byusing two separate groups of patients, one subjected to stimulation andthe other not subjected to stimulation (as a control). Therefore thepost-stimulation benefits would be achieved regardless of whether onewere comparing it to the same population of users before stimulation orto a different population of users acting as a control group.

FIGS. 36A through 36I are a set of graphs illustrating effects ofstimulation on a feeling of hunger as assessed on a VAS (Visual AnalogueScale) in accordance with some embodiments, while FIGS. 37A through 37Iare a set of graphs illustrating effects of stimulation on a feeling ofsatiety as assessed on a VAS in accordance with some embodiments.Referring to FIGS. 36A through 36E, in accordance with an embodiment, asample of 5 patients, having weight loss as an objective or goal, wereassessed for their feeling of hunger (using VAS) at a first occasion,corresponding to a pre-stimulation scenario wherein the 5 patients werenot subjected to stimulation therapy, and at a second occasion,corresponding to a post-stimulation scenario wherein the 5 patients weresubjected to stimulation therapy using an EDP of the presentspecification.

In accordance with an embodiment, the 5 patients were assessed both pre-and post-stimulation using a VAS hunger questionnaire, such as thequestionnaire of FIG. 35A, having a 100 mm VAS line. At the firstoccasion (pre-stimulation), each patient's responses or scores to theVAS hunger questionnaire were recorded at intervals of every 60 minutesstarting from a first response or score 3606 a through 3606 e that, inone embodiment, is recorded just prior to a meal (such as breakfast) butwithout subjecting any of the patients to stimulation therapy. At thesecond occasion (post-stimulation), each patient's responses or scoresto the VAS hunger questionnaire were again recorded at intervals ofevery 60 minutes starting from a first response or score 3607 a through3607 e recorded just prior to the meal (such as breakfast) but afterhaving treated each of the patients with stimulation therapy prior to,for example 30 minutes before, the meal. In accordance with anembodiment, the responses or scores related to the first occasion arerecorded on a first day while those related to the second occasion arerecorded on a second day, preferably at the same time of day and underthe same eating or fasting conditions as the first day.

As shown in FIG. 36A, the first patient's hunger responses or scores forthe first occasion (that is, pre-stimulation) are recorded on a firstday and plotted on a graph, whose x-axis represents time in minutes andy-axis represents VAS hunger responses or scores in millimeters, togenerate a pre-stimulation hunger profile 3605 a. Thereafter, the firstpatient is subjected to stimulation therapy, in accordance toembodiments of the present specification, and the hunger responses orscores for the second occasion (that is, post-stimulation) are alsoplotted on the graph to generate a post-stimulation hunger profile 3608a. Similarly, the second, third, fourth and fifth patients' responses orscores are recorded to generate the respective pre-stimulation hungerprofiles 3605 b, 3605 c, 3605 d, 3605 e and the respectivepost-stimulation hunger profiles 3608 b, 3608 c, 3608 d, 3608 e as shownin FIGS. 36B through 36E. As can be observed from FIGS. 36A through 36E,the post-stimulation huger profiles 3608 a, 3608 b, 3608 c, 3608 d, 3608e reflect reduced hunger magnitude relative to the pre-stimulationhunger profiles 3605 a, 3605 b, 3605 c, 3605 d, 3605 e. In someembodiments, the post-stimulation hunger profile of a patient reflectsat least a 5% decrease in hunger magnitude relative to the patient'spre-stimulation hunger profile.

FIG. 36F shows a first bar 3610 representing a median area under curve(AUC) pre-stimulation hunger score. An AUC value is determined bycalculating the area under the lines which define a given plottedprofile. A second bar 3611 represents a median AUC end-of-stimulationhunger score derived from AUC values for end-of-stimulation hungerprofiles (that is, the hunger profiles recorded starting immediatelyafter the end of stimulation therapy) of the sample patients, and athird bar 3612 represents a median AUC post-stimulation hunger scorederived from AUC values for post-stimulation hunger profiles of thesample patients. In various embodiments, end-of-stimulation is definedas the end of a period of stimulation lasting in a range from onesession to a multitude of sessions over six months. In variousembodiments, post-stimulation is defined as a time after the cessationof therapy and ranges from one day after cessation to six months aftercessation. As shown in the figure, the median AUC hunger scores 3611,3612 corresponding to end-of-stimulation and post-stimulation scenariosare reduced relative to the median AUC hunger score 3610 correspondingto the pre-stimulation scenario. In other words, the stimulation therapyof the present specification results in hunger suppression. In someembodiments, an area under the curve (AUC) of the post-stimulationhunger profile of a patient reflects at least a 5% decrease relative tothe patient's AUC of the pre-stimulation hunger profile.

FIGS. 36G and 36H also illustrate reduced magnitude of hunger scores,for at least one patient, assessed post stimulation relative to thoseassessed pre-stimulation. FIGS. 36G and 36H are charts having x-axisrepresenting time in weeks and y-axis representing hunger scores. FIG.36G shows a pre-stimulation hunger profile 3615 g relative to apost-stimulation hunger profile 3616 g over extended period of timessuch as, in weeks and up to 32 weeks. Similarly, FIG. 36H also shows apre-stimulation hunger profile 3615 h relative to a post-stimulationhunger profile 3616 h over the same extended period of times. As can beobserved from the FIGS. 36G and 36H, the post-stimulation hungerprofiles 3616 g, 3616 h show reduced hunger AUC and magnitude relativeto the respective pre-stimulation hunger profiles 3615 g, 3615 h, evenover extended periods of time.

FIG. 36I is another graph showing a first median or average hunger score3620 (assessed using the VAS hunger questionnaire, such as that of FIG.35A) recorded on a first day prior to subjecting one or more patients tostimulation therapy (pre-stimulation scenario), a second median oraverage hunger score 3622 recorded at the end of subjecting one or morepatients to stimulation therapy (end-of-stimulation scenario) and athird median or average hunger score 3624 recorded on a second day afterhaving subjected one or more patients to stimulation therapy(post-stimulation scenario).

Referring now to FIGS. 37A through 37E, in accordance with anembodiment, a sample of 5 patients, having weight loss as an objectiveor goal, were assessed for their feeling of satiety (using VAS) at afirst occasion, corresponding to a pre-stimulation scenario wherein the5 patients were not subjected to stimulation therapy and at a secondoccasion, corresponding to a post-stimulation scenario wherein the 5patient were subjected to stimulation therapy using an EDP of thepresent specification.

In accordance with an embodiment, the 5 patients were assessed both preand post stimulation using a VAS satiety questionnaire, such as thequestionnaire of FIG. 35D, having a 100 mm VAS line. At the firstoccasion (pre-stimulation), each patient's responses or scores to theVAS satiety questionnaire were recorded at intervals of every 60 minutesstarting from a first response or score 3706 a through 3706 e that, inone embodiment, is recorded just prior to a meal (such as breakfast) butwithout subjecting any of the patients to stimulation therapy. At thesecond occasion (post-stimulation), each patient's responses or scoresto the VAS satiety questionnaire were again recorded at intervals ofevery 60 minutes starting from a first response or score 3707 a through3707 e recorded just prior to the meal (such as breakfast) but afterhaving treated each of the patients with stimulation therapy prior to,for example 30 minutes before, the meal. In accordance with anembodiment, the responses or scores related to the first occasion arerecorded on a first day while those related to the second occasion arerecorded on a second day, preferably at the same time of day and underthe same eating or fasting conditions as the first day.

As shown in FIG. 37A, the first patient's satiety responses or scoresfor the first occasion (that is, pre-stimulation) are recorded on afirst day and plotted on a graph, whose x-axis represents time inminutes and y-axis represents VAS satiety responses or scores inmillimeters, to generate a pre-stimulation satiety profile 3705 a.Thereafter, the first patient is subjected to stimulation therapy, inaccordance to embodiments of the present specification, and the satietyresponses or scores for the second occasion (that is, post-stimulation)are also plotted on the graph to generate a post-stimulation satietyprofile 3708 a. Similarly, the second, third, fourth and fifth patients'responses or scores are recorded to generate the respectivepre-stimulation satiety profiles 3705 b, 3705 c, 3705 d, 3705 e and therespective post-stimulation satiety profiles 3708 b, 3708 c, 3708 d,3708 e as shown in FIGS. 37B through 37E. As can be observed from FIGS.37A through 37E, the post-stimulation satiety profiles 3708 a, 3708 b,3708 c, 3708 d, 3708 e reflect reduced satiety magnitude relative to thepre-stimulation satiety profiles 3705 a, 3705 b, 3705 c, 3705 d, 3705 e.In some embodiments, the post-stimulation satiety profile of a patientreflects at least a 5% increase in satiety magnitude relative to thepatient's pre-stimulation satiety profile.

FIG. 37F shows a first bar 3710 representing a median AUCpre-stimulation satiety score derived from AUC values forpre-stimulation satiety profiles of at least one patient, a second bar3711 representing a median AUC end-of-stimulation satiety score derivedfrom AUC values for end-of-stimulation satiety profiles (that is, thesatiety profiles recorded starting immediately after the end ofstimulation therapy) of the at least one patient and third bar 3712representing a median AUC post-stimulation satiety score derived fromAUC values for post-stimulation satiety profiles of the at least onepatient. In various embodiments, end-of-stimulation is defined as theend of a period of stimulation lasting in a range from one session to amultitude of sessions over six months. In various embodiments,post-stimulation is defined as a time after the cessation of therapy andranges from one day after cessation to six months after cessation. Asshown in the figure, the median AUC satiety scores 3711, 3712corresponding to end-of-stimulation and post-stimulation scenarios areelevated or improved relative to the median AUC satiety score 3710corresponding to the pre-stimulation scenario. In other words, thestimulation therapy of the present specification results in hungersuppression or improved satiety. In some embodiments, an area under thecurve (AUC) of the post-stimulation satiety profile of a patientreflects at least a 5% increase relative to the patient's AUC of thepre-stimulation satiety profile.

FIGS. 37G and 37H also illustrate reduced magnitude of satiety scores,for at least one patient, assessed post stimulation relative to thoseassessed pre-stimulation. FIGS. 37G and 37H are charts having x-axisrepresenting time in weeks and y-axis representing satiety scores. FIG.37G shows a pre-stimulation satiety profile 3715 g relative to apost-stimulation satiety profile 3716 g over extended period of timessuch as, in weeks and up to 32 weeks. Similarly, FIG. 37H also shows apre-stimulation satiety profile 3715 h relative to a post-stimulationsatiety profile 3716 h over the same extended periods of time. As can beobserved from the FIGS. 37G and 37H, the post-stimulation satietyprofiles 3716 g, 3716 h show improved or increased satiety AUC andmagnitude relative to the respective pre-stimulation satiety profiles3715 g, 3715 h, even over extended periods of time.

FIG. 37I is another graph showing a first median or average satietyscore 3720 (assessed using the VAS hunger questionnaire, such as that ofFIG. 35D) recorded on a first day prior to subjecting the at least onepatient to stimulation therapy (pre-stimulation scenario), a secondmedian or average satiety score 3722 recorded at the end of subjectingthe at least one patient to stimulation therapy (end-of-stimulationscenario) and a third median or average satiety score 3724 recorded on asecond day after having subjected the at least one patient tostimulation therapy (post-stimulation scenario).

It should be appreciated that while FIGS. 36A through 36I illustrate preand post hunger levels and FIGS. 37A through 37I illustrate pre and postsatiety levels, in various embodiments, various patient sensations suchas satiation and fullness are also similarly assessed and recorded usingVAS under pre and post stimulation scenarios. It should also beappreciated that the pre-stimulation levels of a patient sensations,such as hunger, appetite, satiety, satiation and fullness, are measuredusing a scale (such as a VAS) at predefined times of day over a firstpredefined period of time, and the post-stimulation levels of thepatient sensations are measured, after stimulation is initiated, usingthe scale at the predefined times of day over a second predefined periodof time, equal in duration to the first predefined period of time. Inaddition, in various embodiments, a patient's change in satiety, definedas an alteration in the patient's perception of gastric fullness oremptiness, is measured using a scale (such as a VAS) to determineefficacy of therapy provided by an EDP device. Further, in variousembodiments, the results obtained by the VAS, not only for change insatiety but for all patient sensations, are used to modify stimulationprovided by the EDP device.

For well-being, in one embodiment and referring to FIG. 16, the patientcan enter a score from 1 to 3, wherein 1 indicates no nausea/abdominaldiscomfort, 2 indicates occasional nausea/abdominal discomfort, and 3indicates the patient is experiencing frequent nausea/abdominaldiscomfort. In some embodiments, for well-being, a higher scoreindicates stimulation is too intense, causing the patient to experiencenausea, and that a reduction in stimulation is needed. The treatmentalgorithm of the companion device recognizes the need for reducedstimulation as indicated by the higher score and titrates therapyaccordingly. For example, in one embodiment, if the patient enters awell-being score of 3 in the patient diary for three consecutive days,the algorithm uses the score to incrementally reduce the number ofstimulation sessions per day or week and/or the length of eachstimulation session. In one embodiment, parameter modifications based onwell-being scores supersede those based on hunger and/or appetitescores. These primary drivers are tracked to determine how best tomodify stimulation on an on-going basis to provide the patient with theproper amount of stimulation such that the patient does not experiencefeelings of nausea, dyspepsia, does not experience low energy orweakness, and does not have too large an appetite or consume too muchfood. The tracking of these variables allows for automatic modificationof stimulation parameters, based on predefined variable ranges andlimits, to provide the patient with a therapeutic stimulation protocolwithout the need of constant management by the patient.

In some embodiments, therapy is further driven by a set of two secondaryindicators. The secondary indicators include patient weight and caloriesexpended/exercise. Weight can be entered in pounds and caloriesexpended/exercises can be attributed a score which is entered into thecompanion device, as depicted in FIGS. 15 and 12. For example, forweight, referring to FIG. 15, the patient can enter his weight in poundsusing a keypad on the companion device. In one embodiment, the patiententers his weight in the patient diary on a weekly basis. In otherembodiments, the companion device is configured to communicatewirelessly with a wireless scale (i.e. bathroom scale) such that thepatient's weight is automatically entered into the companion device whenthe patient weighs himself on the scale. This improves system accuracyby eliminating the possibility of the patient entering an incorrectweight. In addition, the system can track how often and when the patientweighs himself, send reminders, and titrate therapy based on thecommunicated weight. In another embodiment, the companion device isconfigured to communicate wirelessly with a separate body fat measuringdevice. As with the patient's weight, automatic transmission ofcalculated body fat to the companion device results in improved systemaccuracy, body fat measuring tracking and reminders, and therapytitration based on communicated body fat data. In various embodiments,the companion device is configured to communicate wirelessly with aseparate device capable of measuring a plurality of physiologicalparameters, including, but not limited to, patient weight, body fat,lean mass, and body mass index (BMI). Data from these parameters isautomatically input into a treatment algorithm of the companion deviceand is used to drive therapy by modifying electrical stimulationparameters.

For calories expended/exercise, referring to FIG. 12, the patient canenter an exercise score from 1 to 5, wherein 1 indicates the patienttook more than 10,000 steps in a single day, 2 indicates the patienttook 7,500-10,000 steps in a single day, 3 indicates the patient took5,000-7,500 steps in a single day, 4 indicates the patient took2,500-5,000 steps in a single day, and 5 indicates the patient took lessthan 2,500 steps in a single day. In some embodiments, the secondaryindicators further include fitness input (from a separate device, forexample, a device, with physiological sensors, configured to be worn onthe human body, such as around the wrist, in order to monitor, acquire,record, and/or transmit the physiological data) and biological inputs(such as ghrelin levels).

Similar to the primary drivers, these secondary indicators can betracked to determine how best to modify stimulation on an on-going basisto provide the patient with the proper amount of stimulation. In someembodiments, the secondary indicators possess less value compared to theprimary drivers in determining how best to modify the EDP stimulationparameters. Although embodiments having three primary drivers and twosecondary indicators have been discussed, additional embodiments havinggreater or fewer primary drivers and/or secondary indicators arepossible and the variables presented are not intended to be limiting.

The EDP devices of the present specification can be used to enable apatient to comply with a dietary plan. In some embodiments, the systemcalculates, for example, via an application or software on themicroprocessor of the EDP, the timing of food consumption by thepatient, the total calories consumed, and the type of food consumed(i.e. glycemic index, carbohydrate profile, and protein profile). Thesystem then, via an algorithm through said application or software, usesthe calculated information to titrate electrical stimulation therapy.For example, if the patient eats outside his normal dietary time, eatstoo many calories based on his diet, and/or eats foods high in glycemicindex or carbohydrate profile, the system recognizes this and increasesany one or combination of stimulation amplitude, frequency, number ofsessions, session length, or session timing.

Specifically, in various embodiments, the system calculates timing ofconsumption, total calories consumed, and type of food consumed, asdescribed above, along with other parameters such as exercise andon-going weight loss, and, based on the calculations, performs thefollowing therapy adjustments:

-   -   If a patient consumes too many calories, based on his dietary        plan, over a predetermined period (for example, 3 days), the        stimulation duration, intensity, and/or number of sessions is        increased.    -   If a patient consumes too much food at a specific time of day        each day over a predetermined period (for example, 3 days), the        timing of stimulation is changed to prior to (for example, a        half hour or 1 hour before) the overeating time and/or an        additional stimulation session is added prior to the overeating        time.    -   If a patient consumes foods outside his dietary plan, for        example, too many carbohydrates, over a predetermined period        (for example, 3 days), the stimulation duration, intensity,        session timing, and/or number of sessions is increased.    -   If a patient stops exercising for a predetermined period (for        example, 3 days), stimulation parameters are increased.    -   If, following a course of treatment, the patient has lost a        predetermined amount of target weight, the system algorithm        decreases stimulation parameters, in some embodiments either by        a physician or via a downloadable application.

For some patients, compliance becomes easier when the patient does notneed to track the amount of calories in each piece of food consumed butrather is presented with a dietary plan with a listing of foods whereinthe calorie profile of each item of food is already known. Therefore, insome embodiments, the system provides the patient with a number ofbreakfast, lunch, dinner, and optionally snack meal plans from which tochoose. The calorie profile of each of these meal plans ispre-calculated. These calorie profiles are pre-programmed into thesoftware or applications of the EDP device. Patients no longer need totrack the calorie content of each item of food consumed but can simplyreport how well they are complying with the chosen meal plans. Further,in some embodiments, the EDP can be linked to a separate wearabledevice, for example, a device, with physiological sensors, configured tobe worn on the human body, such as around the wrist, in order tomonitor, acquire, record, and/or transmit physiological data, such asexercise data, to the EDP so that calories expended, as tracked by theseparate device, are deducted from calories consumed, as per thespecific meal plans, to provide the patient and system with caloriebalance information.

In some embodiments, patients are instructed to follow a 1200calorie/day diet plan. Based on the above, too many calories consumedabove the baseline 1200 and/or the wrong calories consumed (for example,a bad glycemic index, too many sugars consumed, and/or too manycarbohydrates consumed) will result in an increase in stimulation. Ifpoor eating habits (for example, too many of the wrong calories) areconcentrated at a particular time of day, the system adjusts to add asession just prior to the particular time to lower hunger and improveeating behavior.

In some embodiments, stimulation is programmed to begin before (forexample, 1 week prior to) the patient starts on his dietary plan.Beginning stimulation before the patient changes to a new dietary planreduces the patient's appetite before the change in eating and resultsin better compliance as patients are less likely to become disheartenedif they stray from their diet due to high hunger levels. In otherembodiments, patients only receive stimulation therapy and do not go ona dietary plan.

FIG. 27C is a flow chart illustrating the steps involved in oneembodiment of a method of using an electro-dermal patch device tosuppress appetite in a patient. At step 2702, a patient obtains anelectro-dermal patch (EDP) device, in accordance with the devicesdisclosed in the present specification, from a medical professional.

The EDP device is set into a default operational mode, either by thepatient or by the medical professional, at step 2704. In someembodiments, the default operational mode includes the followingstimulation parameters and parameter ranges: pulse width in a range of10 μsec to 10 msec; pulse amplitude in a range of 100 μA to 500 mA;pulse frequency in a range of 1 Hz to 10,000 Hz; pulse duty cycle in arange of 1% to 100%; session duration in a range of lmin to 120 min orsubstantially continuously; and 1 to 24 sessions per day. In a preferredembodiment, the default operational mode includes the followingstimulation parameters: pulse width equal to 200 μsec; pulse amplitudeequal to 5 mA; pulse frequency equal to 20 Hz; pulse duty cycle equaling100%; session duration equaling 30 minutes; and 1 session per day. Inanother preferred embodiment, the default operational mode is set, formost patients, at 3 daily stimulation sessions of 30 minutes each havingpulse amplitude of 20 mA. Each of the three daily stimulation sessionsis initiated 30 to 60 minutes and preferably 45 minutes prior tomealtimes, such as, breakfast, lunch and dinner, for example. In yetanother preferred embodiment, the baseline stimulation scheme orprotocol is set at 3 daily stimulation sessions of 15 minutes eachhaving a pulse amplitude of 20 mA timed pre-prandial and 60 minutes eachhaving a pulse amplitude of 20 mA timed post-prandial, that isimmediately prior to commencement and upon completion of each meal suchas breakfast, lunch and dinner. In other words, the baseline stimulationscheme or protocol comprises 3×1.25 hours=3.75 hours total (15 minutespre-prandial to each meal and 60 minutes post prandial). In someembodiments, the base line pulse amplitude ranges from 5 mA to 10 mA toenable total stimulation durations that are longer than 3.75 hours. Invarious embodiments, these post-prandial stimulation sessions aretriggered manually by the user. In some alternate embodiments, thepre-prandial and post-prandial stimulation sessions are automaticallytriggered based on pre-stored meal time schedule. In some alternateembodiments, the post-prandial stimulation sessions are automaticallytriggered with reference to a detection of an eating event by a swallowdetection device, such as the device 5605 of FIG. 56, or by the eatingmoment recognition method (FIG. 58) implemented by the HMA using aplurality of data (representing the user's food intake gestures)captured by an accelerometer, wherein the accelerometer is included in awrist-band or wristwatch, such as the band 2105 of FIG. 21A or thewristwatch 2106 of FIG. 21B.

Then, at step 2706, the EDP device is positioned on the patient's body,either by the patient or by the medical professional. The patient isallowed to modify the default operational mode within a set ofpredefined ranges at step 2708. The patient may modify the defaultoperational mode based upon patient feedback or feedback provided by aseparate wearable device, for example, a device, with physiologicalsensors, configured to be worn on the human body, such as around thewrist, in order to monitor, acquire, record, and/or transmit thephysiological data. At step 2710, the EDP device displays appetite,stimulation sessions, caloric intake, and patient weight in a variety ofgraphical user interfaces (GUIs). Other parameters may also be listed,and the list in step 2710 is not intended to be limiting. The EDP deviceforces or allows, through patient input, changes to the operational modein the case of nausea, dyspepsia or habituation or to conserve batteryat step 2712. The EDP device forces the changes when feedback dataprovided by the device or another wearable device falls outside presetranges indicating habituation is occurring. In some embodiments,habituation occurs when hunger returns over time despite electricalstimulation via the stimulation protocols disclosed in the presentspecification.

The return of hunger indicates a loss of appetite suppression due tohabituation of the patient to the electrical stimulation. The patientmay change the operational mode if he or she is experiencing nauseaand/or dyspepsia.

FIG. 28 is a flow chart illustrating the steps involved in anotherembodiment of a method of using an electro-dermal patch device tosuppress appetite in a patient. At step 2802, a patient obtains anelectro-dermal patch (EDP) device, in accordance with the devicesdisclosed in the present specification, from a medical professional. TheEDP device is set into a default operational mode, either by the patientor by the medical professional, at step 2804. In various embodiments,the default operational mode includes the stimulation parameters andparameter ranges listed above with respect to FIG. 27C. Then, at step2806, the EDP device is positioned on the patient's body, either by thepatient or by the medical professional. The EDP device automaticallymodifies the default operational mode based upon predetermined triggersat step 2808. In various embodiments, the triggers include, but are notlimited to, patient diary recording of appetite, hunger, and well-being,and data from a separate device, with physiological sensors, configuredto be worn on the human body, such as around the wrist, in order tomonitor, acquire, record, and/or transmit the physiological data, datatransmitted to the companion device. For example, in one embodiment, thepatient records an appetite diary entry with a score of 5, wherein thepatient substantially exceeded his diet during his most recent meal,indicative of dietary non-compliance (that is, not conforming to a dietplan) or poor dietary compliance. In some embodiments, one or morescores of 5 on appetite triggers the companion device to automaticallyincrease therapy parameters, for example, an increase in stimulationintensity, duration, or sessions.

In another embodiment, for example, the patient records a hunger diaryentry with a score of 1, wherein the patient experienced no hunger atall at his most recent meal time. In some embodiments, one or morescores of 1 on hunger triggers the companion device to automaticallydecrease therapy parameters, for example, a decrease in stimulationintensity, duration, or sessions. At step 2810, the EDP device displaysappetite, stimulation sessions, caloric intake, and patient weight in avariety of graphical user interfaces (GUIs). Other parameters may alsobe listed, and the list in step 2810 is not intended to be limiting. TheEDP device then follows a ramp down procedure, wherein stimulationparameters are decreased sequentially, to conserve battery and avoidpotential habituation at step 2812.

FIG. 29 is a flow chart illustrating the steps involved in anotherembodiment of a method of using an electro-dermal patch device tosuppress appetite in a patient. At step 2902, a patient obtains anelectro-dermal patch (EDP) device, in accordance with the devicesdisclosed in the present specification, from a medical professional. TheEDP device is set into a default operational mode, either by the patientor by the medical professional, at step 2904. In various embodiments,the default operational mode includes the stimulation parameters andparameter ranges listed above with respect to FIG. 27C. Then, at step2906, the EDP device is positioned on the patient's body, either by thepatient or by the medical professional. The EFP device automaticallymodifies the default operational mode after a predefined number of daysof a patient diary record of appetite or hunger at step 2908. In variousembodiments, the predefined number of days is in a range of 1 to 7 days.In one embodiment, the predefined number of days is 3 days. In oneembodiment, in combination with step 2908, the EDP device allows thepatient to manually adjust stimulation parameters to address nausea,dyspepsia or provide an emergency stimulation to address hunger at step2910. At step 2912, the EDP device displays appetite, stimulationsessions, caloric intake, and patient weight in a variety of graphicaluser interfaces (GUIs). Other parameters may also be listed, and thelist in step 2912 is not intended to be limiting. The EDP device thenfollows a ramp down procedure, wherein stimulation parameters aredecreased sequentially, to conserve battery and avoid potentialhabituation at step 2914.

FIG. 30 is a flow chart illustrating the steps involved in anotherembodiment of a method of using an electro-dermal patch device tosuppress appetite in a patient. At step 3002, a patient obtains anelectro-dermal patch (EDP) device, in accordance with the devicesdisclosed in the present specification, from a medical professional. TheEDP device is set into a default operational mode, either by the patientor by the medical professional, at step 3004. In various embodiments,the default operational mode includes the stimulation parameters andparameter ranges listed above with respect to FIG. 27C. Then, at step3006, the EDP device is positioned on the patient's body, either by thepatient or by the medical professional. The EFP device automaticallymodifies the default operational mode after a predefined amount ofcalorie consumption or calories burned, as determined by diary entriesor information gathered from a separate device, or after a predefinednumber of days of weight data has been recorded at step 3008. In variousembodiments, the predefined number of days is in a range of 1 to 7 days.In one embodiment, the predefined number of days is 3 days. In oneembodiment, in combination with step 3008, the EDP device allows thepatient to manually adjust stimulation parameters to address nausea,dyspepsia or provide an emergency stimulation to address hunger at step3010. At step 3012, the EDP device displays appetite, stimulationsessions, caloric intake, and patient weight in a variety of graphicaluser interfaces (GUIs). Other parameters may also be listed, and thelist in step 3012 is not intended to be limiting. The EDP device thenfollows a ramp down procedure, wherein stimulation parameters aredecreased sequentially, to conserve battery and avoid potentialhabituation at step 3014.

FIG. 31 is a flow chart illustrating the steps involved in yet anotherembodiment of a method of using an electro-dermal patch device tosuppress appetite in a patient. At step 3102, the patient obtains anelectro-dermal patch (EDP) device and pairs the EPD device with acompanion device, such as a smartphone, and a separate device, forexample, a device, with physiological sensors, configured to be worn onthe human body, such as around the wrist, in order to monitor, acquire,record, and/or transmit the physiological data. In some embodiments,pairing with the separate device can be done anytime within a treatmentcycle. In some embodiments, a treatment cycle lasts 3 months. At step3104, the device is set into a default operational mode. In someembodiments, the default operational mode includes the stimulationparameters and parameter ranges listed above with respect to FIG. 27Cand includes daily stimulation.

The EDP device is positioned on the patient's body at step 3106. At step3108, the companion device accumulates patient variable data, including,but not limited to, appetite, hunger, well-being, weight, and caloriesexpended/weight loss, in a patient diary over a predefined period oftime. In some embodiments, the companion device accumulates data over arange of 1 to 7 days. In one embodiment, the companion deviceaccumulates data for 3 days. Then, at step 3110, the companion devicedrives stimulation therapy wirelessly through the EDP device based onaccumulated patient diary data over the treatment cycle. During thetreatment cycle, if the patient experiences nausea and/or dyspepsia, thecompanion device ramps down stimulation parameters quickly at step 3112.During the treatment cycle, if the patient experiences satiety, definedas the absence of hunger coupled with good dietary compliance, thecompanion device slowly lowers stimulation to a minimum threshold, suchas one 15 minute stimulation session every other day, to preservebattery and prevent habituation, or leaves stimulation unchanged at step3114. During the treatment cycle, if the patient experiences hunger isdietary non-compliant, the companion device ramps up stimulationaccordingly at step 3116. At step 3118, the companion device modifiesstimulation based upon actual weight loss, measured ghrelin levels, orestimated calories expended during the treatment cycle. In oneembodiment, the companion device uses a weight loss predictor algorithmbased on caloric input versus caloric consumption. At step 3120, thecompanion device displays a composite score measuring overall successderived from the variable inputs. If the patient is non-compliant, thecompanion device will provide audible and/or visual reminders to thepatient at step 3122. Optionally, at step 3124, the companion deviceprovides the patient with the option of sharing his results via socialmedia with designated friends and family.

In an alternate embodiment, the companion device first accumulatespatient diary data before the EDP device is set into the defaultoperation mode. Referring to FIG. 31, in this alternate embodiment, step3108 is performed prior to step 3104. The remaining steps proceed in thesame order.

In other embodiments, a patient is provided with manual options ofoperating the EDP device. The patient may operate the device at low,medium, and high settings, based on the patient variable data. Forexample, in one embodiment, a patient starts the EDP device at a highsetting but begins to experience nausea and/or dyspepsia. The patientthen resets the EDP device to the medium setting, and then to the lowsetting. Eventually, the patient experiences hunger and resets the EDPdevice to the medium setting. In some embodiments, this protocol isdriven by a therapy intensity scale, such as 1 to 5 or 1 to 10, or agraphic on the display of the companion device. In some embodiments,manual operation using low, medium, and high settings is coupled withthe protocols described with reference to FIGS. 27C-31 to establishbaseline EDP device settings.

FIG. 32 is a flow chart illustrating the steps involved in yet otherembodiments of methods of using an electro-dermal patch device tosuppress appetite in a patient. At step 3202, a patient receivesinstructions from a medical professional, receives an electro-dermalpatch (EDP) device, and downloads a patient diary application to acompanion device, such as a smartphone. Optionally, at step 3204, thepatient wears the EDP immediately, turns it on, and pairs it with thecompanion device such that the companion device begins recordingappetite, hunger, and well-being parameters in the patient diaryapplication. In one embodiment, the EDP then initiates default parametersetting therapy (i.e. every other day, 1×/day for 30 min) with nopatient input required at step 3212. The patient diary application thenaccumulates key data, such as appetite, hunger, and well-being (i.e.nausea, dyspepsia, energy level, weakness/fatigue) over a predefinedtime period at step 3216. After a minimum time period (i.e. 3 days) haselapsed at step 3218, the patient diary application initiates amodification to the default parameter setting, which may or may notresult in immediate stimulation, wherein the modification may include anincrement or a decrement to any stimulation or timing variable.

Alternatively, in another embodiment, following step 3204 wherein thepatient wears the EDP immediately, the patient diary applicationprovides the patient various options (i.e. high, medium, and lowappetite control) at step 3214 and, based upon the selected option,initiates a partially tailored parameter setting. The patient diaryapplication then continues to accumulate key data and initiate parametersetting modifications, as detailed in steps 3216 and 3218 respectively.

Optionally, in another embodiment, following step 3202 wherein thepatient receives the EDP and downloads the patient diary application,the patient does not wear the EDP immediately at step 3206, but firstturns the EDP on, pairs it with the companion device, and beginsrecording key data parameters, such as appetite, hunger, and well-being,in the patient diary application. At step 3222, once the patient diaryapplication has accumulated key data over a predefined time period, thepatient is instructed by the application to wear the EDP. Then, at step3224, once the companion device receives confirmation that the EDP isbeing worn, the patient diary application initiates a custom stimulationprotocol developed by the patient diary application based on theaccumulated data, which may or may not result in immediate stimulation.Based on on-going key data input, at step 3226, the patient diaryapplication may initiate further modifications to the parametersettings, which may or may not result in immediate stimulation, whereinthe modifications may include an increment or a decrement to anystimulation or timing variable.

Still optionally, in another embodiment, following step 3202 wherein thepatient receives the EDP and downloads the patient diary application,the patient does not wear the EDP immediately at step 3208, but firstturns the EDP on, pairs the EDP with the companion device, pair thecompanion device with another wearable device, for example, a device,with physiological sensors, configured to be worn on the human body,such as around the wrist, in order to monitor, acquire, record, and/ortransmit the physiological data, and begins recording key dataparameters, such as appetite, hunger, and well-being, as well as datafrom the other wearable device, such as fitness/exercise, in the patientdiary application. At step 3232, once the patient diary application hasaccumulated key data and data from the other wearable device over apredefined time period, the patient is instructed by the application towear the EDP. Then, at step 3234, once the companion device receivesconfirmation that the EDP is being worn, the patient diary applicationinitiates a custom stimulation protocol developed by the patient diaryapplication based on all accumulated data, which may or may not resultin immediate stimulation. Based on on-going key data input and on-goinginput from the other wearable device, at step 3236, the patient diaryapplication may initiate further modifications to the parametersettings, which may or may not result in immediate stimulation, whereinthe modifications may include an increment or a decrement to anystimulation or timing variable.

FIG. 33 is a flow chart illustrating the steps involved in a using anelectro-dermal patch device and a companion device, paired with aseparate monitoring device, to suppress appetite in a patient, inaccordance with one embodiment of the present specification. At step3302, the patient obtains an EDP from a medical professional. Thepatient pairs a companion device with the EDP and with a separatemonitoring device at step 3304. The separate monitoring device isconfigured to measure a plurality of physiological parameters,including, but not limited to, patient weight, body fat, lean mass, andBMI, and wirelessly transmit monitored data to the companion device. Thepatient then positions the EDP on his body at step 3306. At step 3308,the companion device sets the EDP into a default stimulation mode basedon initial physiological data gathered from the separate monitoringdevice. Based on on-going data gathering an input, the companion devicecontinually modifies the electrical stimulation provided by the EDP inan effort to suppress appetite in the patient at step 3310. Optionally,at step 3312, the patient manually adjusts stimulation parameters basedon patient well-being, for example, lowering stimulation parameters ifthe patient is experiencing nausea, dyspepsia or discomfort at thestimulation site.

FIG. 34 is a flow chart illustrating the steps involved in still anotherembodiment of a method of using an electro-dermal patch device tosuppress appetite in a patient. At step 3402, the patient obtains anelectro-dermal patch (EDP) device and pairs the EPD device with acompanion device, such as a smartphone, and a separate device, forexample, a device, with physiological sensors, configured to be worn onthe human body, such as around the wrist, in order to monitor, acquire,record, and/or transmit the physiological data. In some embodiments,pairing with the separate device can be done anytime within a treatmentcycle. In some embodiments, a treatment cycle lasts 3 months. At step3404, the device is set into a default operational mode. In someembodiments, the default operational mode includes the stimulationparameters and parameter ranges listed above with respect to FIG. 27Cand includes daily stimulation.

The EDP device is positioned on the patient's body at step 3406. At step3408, the companion device accumulates patient variable data, including,but not limited to, actual eating and meals profile of the user such asthe time of consumption of a meal in a day and the type and amount offood eaten at the meal, standard regular eating and meals routine of theuser, such as a standard diet plan (such as, but not limited to,Mediterranean, Zone Diet, Atkins Diet, Ketogenic Diet, IntermittentFasting, Jenny Craig, and Custom Plan), appetite, hunger, well-being,weight, and calories expended/weight loss, in a patient diary over apredefined period of time. In some embodiments, the companion deviceaccumulates data over a range of 1 to 7 days. In one embodiment, thecompanion device accumulates data for 3 days. Then, at step 3410, thecompanion device drives stimulation therapy wirelessly through the EDPdevice based on accumulated patient diary data over the treatment cycle.

During the treatment cycle, if the patient has a positive or surplusenergy balance (representative of more actual calories consumed incomparison to the calories expended) over a predefined period of time,for example, 3 days, the companion device ramps up stimulationparameters (such as, by increasing the stimulation duration, intensityand/or number of sessions) at step 3412. During the treatment cycle, ifthe patient exceeds the glycemic load (calculated based on the patient'sactual eating and meals profile input into the patient diary), comparedto the allowed glycemic load as estimated based on the patient'sstandard diet plan, over a predefined period of time, for example, 3 to5 days, the companion device ramps up stimulation parameters at step3414. Alternatively or additionally, at steps 3412 and 3414, thecompanion device ramps up stimulation parameters if the patient recordsan appetite diary entry with a score of 5, for example, for 3 to 5 days,indicative of poor or no dietary compliance with reference to thepatient's standard diet plan. Thus, in some embodiments, the HealthManagement application uses the appetite parameter, which is indicativeof the patient's dietary compliance, to assess if the patient is likelyto be at a surplus energy balance and exceed the allowable glycemicload.

During the treatment cycle, if the patient exceeds the total number ofmeals per day over a predefined period of time, compared to the numberof meals allowed according to the patient's standard diet plan, thecompanion device may include additional stimulation sessions just prior(for example, a half hour or an hour prior) to the extra meal events atstep 3416. At step 3418, if the patient overeats at a specific time andcontinues to depict such overeating behavior over a predefined period oftime, for example, 3 to 5 days, the companion device may change thetiming of stimulation to just prior (for example, a half hour or an hourprior) to the overeating meal event or time or may include an additionalstimulation session just prior to the overeating meal event. In someembodiments, the energy balance and glycemic load are calculated forevery meal of the day, which in turn enables calculation of the mealthat contributes the highest percentage of calories (or energy surplus)and glycemic load for the day. This meal, which contributes the highestpercentage of calories and glycemic load per day over a predefinedperiod of time, is identified as the overeating meal event.

During the treatment cycle, if the patient stops exercising for apredefined period of time, for example 3 to 5 days, or if the patienthas an exercise score of 5 (FIG. 12), indicating the least level ofexpected exercising and therefore calories expended, and is also at asurplus energy balance for a predefined period of time (for example 3 to5 days), the companion device ramps up stimulation parameters at step3420. At step 3422, following a treatment course or cycle, once thepatient has lost sufficient weight or achieved a target weight, thecompanion device modifies stimulation parameters to a maintenance modewherein the stimulation parameters such as stimulation intensity,duration and number of sessions are all lowered.

Optionally, at step 3424, the companion device provides the patient withthe option of sharing his results via social media with designatedfriends and family. In an alternate embodiment, the companion devicefirst accumulates patient diary data before the EDP device is set intothe default operation mode. Referring to FIG. 34, in this alternateembodiment, step 3408 is performed prior to step 3404. The remainingsteps proceed in the same order.

FIG. 49 is a flow chart illustrating the steps involved in oneembodiment of a method of using an electro-dermal patch device toautomatically drive rescue therapy based on the user's individualizedhunger profile or map. At step 4902, a patient obtains an electro-dermalpatch (EDP) device, in accordance with the devices disclosed in thepresent specification, from a medical professional.

The EDP device is set into a default operational mode, either by thepatient or by the medical professional, at step 4904. In someembodiments, the default operational mode or the baseline stimulationprotocol is set at 3 daily stimulation sessions of 30 minutes eachhaving a pulse amplitude of 20 mA. Each of the three daily stimulationsessions is initiated 30 to 60 minutes and preferably 45 minutes priorto scheduled or planned mealtimes, such as, breakfast, lunch and dinner,for example, or any other scheduled mealtimes in accordance with theuser's diet plan. In a preferred embodiment, the baseline stimulationscheme or protocol is set at 3 daily stimulation sessions of 15 minuteseach having a pulse amplitude of 20 mA timed pre-prandial and 60 minuteseach having a pulse amplitude of 20 mA timed post-prandial, that isimmediately prior to commencement and upon completion of each meal suchas breakfast, lunch and dinner. In other words, the baseline stimulationscheme or protocol comprises 3×1.25 hours=3.75 hours total (15 minutespre-prandial to each meal and 60 minutes post prandial). In someembodiments, the base line pulse amplitude ranges from 5 mA to 10 mA toenable total stimulation durations that are longer than 3.75 hours. Invarious embodiments, these post-prandial stimulation sessions aretriggered manually by the user. In some alternate embodiments, thepre-prandial and post-prandial stimulation sessions are automaticallytriggered based on pre-stored meal time schedule. In some alternateembodiments, the post-prandial stimulation sessions are automaticallytriggered with reference to a detection of an eating event by a swallowdetection device, such as the device 5605 of FIG. 56, or by the eatingmoment recognition method (FIG. 58) implemented by the HMA using aplurality of data (representing the user's food intake gestures)captured by an accelerometer, wherein the accelerometer is included in awrist-band or wristwatch, such as the band 2105 of FIG. 21A or thewristwatch 2106 of FIG. 21B.

At step 4906, the EDP device is positioned on the patient's body, eitherby the patient or by the medical professional, to begin deliveringstimulation treatment in accordance with the baseline stimulationprotocol.

At step 4908, in a certain week (for example, the first week oftreatment), the user records an intensity or level of hunger as well asthe date and time of an unplanned or unscheduled hunger event—that is ahunger event that does not comply with the timings of the user's plannedor scheduled mealtimes. In various embodiments, the user uses a lightbar Visual Analog Scale (VAS) on his smartphone (that functions as acompanion device) to record the level of hunger along with the date andtime of the hunger event. In some embodiments, the light bar VAS isconfigured as a 0 to 10 scale wherein 0 represents no hunger while 10represents a maximum level of hunger. Thereafter, at step 4910, if therecorded level of hunger intensity is less than 5, on the VAS, thehunger event is recorded as a low intensity hunger event along with thedate and time of the hunger event but no corresponding rescue session istriggered. The recorded date, time and level of the hunger event areused to generate and display an individualized hunger profile or map ofthe user.

However, at step 4912, if the recorded level of hunger intensity isequal to or greater than 5, the hunger event is recorded as anactionable hunger event. Consequently, the following actions are taken:a) at step 4914, a rescue session duration is determined. In variousembodiments, the rescue session duration is equal to the level of hungerrecorded on the light bar VAS. For example, if the recorded hunger levelis 6 then the duration of the corresponding rescue session is determinedto be equal to 6 minutes. In some embodiments, the level of hungerrecorded on the light bar VAS may alternately or additionally affect therescue session intensity. For example, if the recorded hunger level is 6then the duration of corresponding rescue session is 6 minutes and/orthe intensity of the rescue session is kept at a first intensity level.Similarly, if the recorded hunger level is 8 then the duration ofcorresponding rescue session is 8 minutes and/or the intensity of therescue session is kept at a second intensity level. The first intensitylevel is different from the second intensity level. In embodiments, thefirst intensity level is lower than the second intensity level. Inembodiments, the first intensity level is greater than the secondintensity level. b) At step 4916, the determined rescue session durationis compared with the user's daily discretionary rescue budget. In someembodiments, the user's daily discretionary rescue budget is predefinedto be 30 minutes. If the determined rescue session duration falls withinthat day's discretionary rescue budget then the rescue session therapyis triggered and delivered to the user for the determined rescueduration. On the other hand, if the determined rescue session durationfalls outside that day's discretionary rescue budget then the user and aremote patient care facility or personnel are alerted and the rescuesession therapy is either denied or delivered to the user only afterapproval from the remote patient care facility or personnel. c) At step4918, the date, time and level of hunger are recorded to determine iffilter or threshold condition(s) are met to ascertain if the hungerevent forms a pattern of recurrent hunger pangs or spikes. As discussedearlier in the specification, the filter or threshold conditions maycomprise a predefined period of time (ranging from a few days, say 5 to7 days, to weeks, say 3 to 6 weeks) and/or a predefined number of rescuesessions (ranging from 1 to 10 sessions). Alternatively or additionally,the filter or threshold condition may comprise a combination of criteriasuch as, for example, a minimum of, say, 3 hunger events (eachtriggering a rescue session or bolus—that is, each of the 3 hunger eventbeing of an intensity level greater than or equal to 5 on a 0 to 10light bar VAS) recorded on 3 separate days in the same week and within,say, 60 minutes of the same time of day. The recorded date, time andlevel of the hunger event are also used to generate and display anindividualized hunger profile or map of the user.

At step 4920, if the actionable hunger event meets or satisfies thefilter or threshold condition(s) then a rescue session of, say, 5 or 10minutes is automatically scheduled, for a subsequent week of therapy(for example, the second week of treatment), at the recorded time of theactionable hunger event. In various embodiments, the automaticscheduling of the rescue session in the subsequent week is subject to adaily automatic rescue budget for the subsequent week. That is, therescue session is automatically scheduled for the subsequent week onlyif the duration of the rescue session falls within the automatic rescuebudget for the subsequent week. In some embodiments, the user's dailyautomatic rescue budget is predefined to be 30 minutes.

The steps 4908 to 4920 are repeated for every week, for each occurrenceof an unscheduled hunger event, throughout the duration of thestimulation therapy for the user. Thus, by repeating steps 4908 to 4920for every unscheduled hunger event in a week an automatic rescuedelivery plan or schedule is generated that week—for a subsequent week.The automatic rescue delivery plan or schedule progresses along with thebaseline stimulation protocol throughout the treatment cycle for theuser. It should be appreciated, that since unscheduled hunger events arecontinued to be recorded throughout the treatment cycle, therefore, ifthe user records fewer actionable hunger events in a week there will bea reduced number and/or level of automatic rescue deliveries in asubsequent week and vice versa.

As discussed earlier, the user is allowed a predefined amount of dailytotal rescue budget that, in various embodiments, is a sum of the dailydiscretionary rescue budget and the daily automatic rescue budget. Insome embodiments, the daily total rescue budget is set at, say, 60minutes while the daily discretionary and automatic rescue budgets areset at, say, 30 minutes each. In alternate embodiments, the daily totalrescue budget may be set at lesser or higher values and the dailydiscretionary and automatic rescue budgets may also comprise differentpercentages of the total rescue budget.

FIG. 50 is a flow chart illustrating the steps involved in oneembodiment of a method of using an electro-dermal patch device toautomatically titrate or modulate therapy based on the user's dynamicwell-being profile representing occurrence of nausea and/or dyspepsiaevents. At step 5002, a patient obtains an electro-dermal patch (EDP)device, in accordance with the devices disclosed in the presentspecification, from a medical professional.

The EDP device is set into a default operational mode, either by thepatient or by the medical professional, at step 5004. In someembodiments, the default operational mode or the baseline stimulationprotocol is set at 3 daily stimulation sessions of 30 minutes eachhaving a pulse amplitude of 20 mA. Each of the three daily stimulationsessions is initiated 30 to 60 minutes and preferably 45 minutes priorto scheduled or planned mealtimes, such as, breakfast, lunch and dinner,for example, or any other scheduled mealtimes in accordance with theuser's diet plan. In a preferred embodiment, the baseline stimulationscheme or protocol is set at 3 daily stimulation sessions of 15 minuteseach having a pulse amplitude of 20 mA timed pre-prandial and 60 minuteseach having a pulse amplitude of 20 mA timed post-prandial, that isimmediately prior to commencement and upon completion of each meal suchas breakfast, lunch and dinner. In other words, the baseline stimulationscheme or protocol comprises 3×1.25 hours=3.75 hours total (15 minutespre-prandial to each meal and 60 minutes post prandial). In someembodiments, the base line pulse amplitude ranges from 5 mA to 10 mA toenable total stimulation durations that are longer than 3.75 hours. Invarious embodiments, these post-prandial stimulation sessions aretriggered manually by the user. In some alternate embodiments, thepre-prandial and post-prandial stimulation sessions are automaticallytriggered based on pre-stored meal time schedule. In some alternateembodiments, the post-prandial stimulation sessions are automaticallytriggered with reference to a detection of an eating event by a swallowdetection device, such as the device 5605 of FIG. 56, or by the eatingmoment recognition method (FIG. 58) implemented by the HMA using aplurality of data (representing the user's food intake gestures)captured by an accelerometer, wherein the accelerometer is included in awrist-band or wristwatch, such as the band 2105 of FIG. 21A or thewristwatch 2106 of FIG. 21B.

At step 5006, the EDP device is positioned on the patient's body, eitherby the patient or by the medical professional, to begin deliveringstimulation treatment in accordance with the baseline stimulationprotocol.

At step 5008 the user records an intensity or level of nausea and/ordyspepsia as well as the date and time of occurrence of the nauseaand/or dyspepsia event. In various embodiments, the user uses a lightbar Visual Analog Scale (VAS) on his smartphone (that functions as acompanion device) to record the level of nausea and/or dyspepsia alongwith the date and time of the event. In some embodiments, the light barVAS is configured as a 0 to 10 scale wherein 0 represents no nauseaand/or dyspepsia (that is, the highest level of well-being) and 10represents the most intense level of nausea and/or dyspepsia (that is,the worst level of well-being).

Thereafter, at step 5010, if the recorded level of nausea and/ordyspepsia intensity is less than or equal to a threshold level, say 3,on the VAS, the nausea and/or dyspepsia event is recorded as a lowintensity event along with the date and time of the event but no actionis triggered. The recorded date, time and level of the nausea and/ordyspepsia event are used to generate and display an individualizedwell-being profile or map of the user. However, at step 5012, if therecorded level of nausea and/or dyspepsia intensity is greater than 3,the nausea and/or dyspepsia event is recorded as a high intensity, andtherefore, actionable event resulting in titration or modulation of theongoing stimulation therapy protocol. The date, time and level of thenausea and/or dyspepsia event are again recorded to feed into generatingthe user's well-being profile or map.

It should be appreciated that in alternate embodiments, the therapytitration or modulation is based on the user's quality of life VAS level(instead of nausea and/or dyspepsia events) where a low quality of lifelevel may reduce stimulation intensity and/or duration.

FIG. 57 is a flow chart illustrating the steps involved in oneembodiment of a method of using an electro-dermal patch device to elicitfeedback, coaching or advice related to a medical condition of apatient, from at least one of a social network group (or affinity group)and an online coaching or concierge service, care-provider or physician.In embodiments, the online coaching or concierge service is an algorithmdriven automated virtual coach and/or an actual coach person,care-provider, dietician or physician in communication with the affinitygroup and/or the EDP (or companion device) of the patient. In variousembodiments, the patient's medical condition comprises conditions suchas, but not limited to, obesity, high levels of hunger, appetite, weightand/or low level of well-being. At step 5702, a patient obtains anelectro-dermal patch (EDP) device, in accordance with the devicesdisclosed in the present specification, from a medical professional.

The EDP device is set into a default operational mode, either by thepatient or by the medical professional, at step 5704, and is synced orpaired with a corresponding client or companion device implementing aHealth Management application (HMA) of the present specification. Insome embodiments, the default operational mode or the baselinestimulation protocol is set at 3 daily stimulation sessions of 30minutes each having a pulse amplitude of 20 mA. Each of the three dailystimulation sessions is initiated 30 to 60 minutes and preferably 45minutes prior to scheduled or planned mealtimes, such as, breakfast,lunch and dinner, for example, or any other scheduled mealtimes inaccordance with the user's diet plan. In a preferred embodiment, thebaseline stimulation scheme or protocol is set at 3 daily stimulationsessions of 15 minutes each having a pulse amplitude of 20 mA timedpre-prandial and 60 minutes each having a pulse amplitude of 20 mA timedpost-prandial, that is immediately prior to commencement and uponcompletion of each meal such as breakfast, lunch and dinner. In otherwords, the baseline stimulation scheme or protocol comprises 3×1.25hours=3.75 hours total (15 minutes pre-prandial to each meal and 60minutes post prandial). In some embodiments, the base line pulseamplitude ranges from 5 mA to 10 mA to enable total stimulationdurations that are longer than 3.75 hours. In various embodiments, thesepost-prandial stimulation sessions are triggered manually by the user.In some alternate embodiments, the pre-prandial and post-prandialstimulation sessions are automatically triggered based on pre-storedmeal time schedule. In some alternate embodiments, the post-prandialstimulation sessions are automatically triggered with reference to adetection of an eating event by a swallow detection device, such as thedevice 5605 of FIG. 56, or by the eating moment recognition method (FIG.58) implemented by the HMA using a plurality of data (representing theuser's food intake gestures) captured by an accelerometer, wherein theaccelerometer is included in a wrist-band or wristwatch, such as theband 2105 of FIG. 21A or the wristwatch 2106 of FIG. 21B. In someembodiments, the baseline stimulation protocol includes parametershaving a pulse width in a range of 10 μsec to 10 msec, a pulse amplitudein a range of 100 μA to 100 mA, and a pulse frequency in a range of 1 Hzand 100 Hz.

At step 5706, the EDP device is positioned on the patient's body, eitherby the patient or by the medical professional, to begin deliveringstimulation treatment in accordance with the baseline stimulationprotocol. In various embodiments, the patient, through his EDP, is incommunication with one or more remote servers enabling the patient to bein communication with at least one of a social network group (oraffinity group) and an online coaching or concierge service,care-provider or physician.

At step 5708 the patient inputs or records (as a result of a prompt bythe HMA) an intensity, degree or level of a plurality of health statusdata or parameters such as a degree or level of appetite, hunger,exercise and well-being. In some embodiments, the HMA prompts thepatient to input data indicative of the patient's the degree ofappetite, hunger, exercise and well-being via a microphone or display ofthe client device. In various embodiments, the user uses a light barVisual Analog Scale (VAS) on his smartphone (that functions as theclient or companion device) to record the level of the health statusdata or parameters. In some embodiments, the light bar VAS is configuredas a 0 to 10 or a 0 to 5 scale wherein 0 represents the lowest intensityor degree of the health status parameters and 10 or 5 represent thehighest intensity of the health status parameters. In some embodiments,the patient is visually displayed or prompted with a plurality of iconsor emoticons wherein each of the plurality of icons is representative ofa different degree of health status parameters such as hunger orappetite. In some embodiments, the HMA solicits inputs regarding thehealth status, such as, degree of appetite or hunger by generating aplurality of auditory inquires played via a speaker of the clientdevice. It should be appreciated that in alternate embodiments, an IPAsystem (in communication with the HMA) may prompt the patient to receivevoice based inputs from the patient regarding his health status, suchas, the degree of appetite or hunger.

At step 5710, the patient shares one or more of a plurality of data(shareable date) with at least one of an online social network group oraffinity group (to which the patient subscribes to as a member) and anonline coaching or concierge service. The plurality of data comprises alevel, degree, score or value related to historical and/or currenthunger, appetite, exercise, weight, well-being, will-power, urge to eatprofile, hunger profile, standard eating and meals profile, actualeating and meals profile, dietary plan, exercise regimen, energybalance, weight changes, glucose data, rescue bolus events,default/baseline or current stimulation parameters, protocols andstimulation induced nausea, dyspepsia, and habituation events. It shouldbe appreciated that in various embodiments, the patient shares anycombination, composite function/score (derived from any one or anycombination of the shareable data) or sub-set of the aforementionedplurality of data. In some embodiments, the patient shares (manually orautomatically as triggered by the HMA) at least one or any combinationof: a weight trend of the patient, a plurality of values indicative ofthe patient's historical degrees of appetite, a plurality of valuesindicative of the patient's historical amount of exercise and aplurality of values indicative of the patient's historical well-being.Additionally, the HMA determines a composite score of the patient,wherein said composite score is a function of any two or more of thepatient's historical degrees of appetite, weight trend, historicalwell-being, and historical amount of exercise, and causes the compositescore to be displayed on the client or companion device. The compositescore may additionally or alternatively be shared by the patientmanually or automatically, as triggered by the HMA, members of thesocial network group or affinity group and/or the online coachingservice.

In some embodiments, the plurality of data is automatically shared withthe online social network group or affinity group if at least a sub-setof the plurality of data is determined to indicate deteriorating orlagging medical condition of the patient. It should be noted that insome embodiments, the online coaching or concierge service is incommunication with the social network group and/or the EDP (or companiondevice) of the patient and is enabled to access or automatically receivethe plurality of data related to the patient.

In an embodiment, the plurality of data (shareable data) isautomatically shared with the online social network group or affinitygroup and/or the online coaching service (including an actual coachperson, dietician or caregiver) if the patient records an appetite orhunger score/level above a predefined threshold score/level. In someembodiments, the threshold score/level for appetite or hunger is 5.5 (ona scale of 0 to 10). For example, an appetite or hunger score/level inthe range of 5.5 to 8.5 would trigger an automatic sharing of thepatient's shareable data with the online social network group oraffinity group and/or the online coaching service (including an actualcoach person, dietician or caregiver). An appetite or hunger score/levelabove 8.5 would not only trigger automatic sharing of the patient'sshareable data but also convey the severity of the condition by, forexample, repeatedly flashing the patient's shareable data in brightshades, such as red, to the members of the online social network groupor affinity group.

In accordance with an aspect of the present specification, at least onehealth status data or shareable data, such as for example a hunger eventor a rescue therapy event, input or recorded by the patient and/or acomposite score or function derived from the patient's health statusdata or shareable data is automatically shared, in real-time, with theaffinity group and/or the online coaching service to trigger real-timecoaching, advise or feedback from the online coaching service and/or theaffinity group. It should be appreciated that the coaching or advise iswith an automated virtual coach or sponsor in some embodiments, while inother embodiments such coaching or advice is provided, additionally oralternatively, by an actual coach person, care-provider, dietician orphysician in communication with the affinity group and/or the EDP (orcompanion device) of the patient.

Members of the social network group or affinity group and/or the onlinecoaching service are enabled to provide a plurality of interventions asadvice or response to the shared plurality of data of the patient. Invarious embodiments, the plurality of interventions or responsescomprise elements such as, but not limited to, coaching instructions,encouraging messages (pre-recorded and/or real-time), morale boostingemojis, stimulation parameters and protocols related to members who aredetermined to have improved their medical condition, modified exerciseregimen, and modified dietary plan.

In accordance with aspects of the present specification, the pluralityof interventions, advice or responses of the social network group oraffinity group and/or the online coaching service varies depending uponthe level of deteriorating condition of the patient as indicated by theshared plurality of data. In embodiments, members of the social networkgroup or affinity group and/or the online coaching service areencouraged to input videos, GIFs (Graphics Interchange Format), textmessages and/or emojis that may be encouraging or excoriating dependingon severity of the patient's condition as indicated through the sharedplurality of data. Such videos, GIFs, text messages and/or emojis may bepre-stored for automatic delivery to the patient, when in need and inaccordance with the severity of condition of the patient.

At step 5712 a, the HMA determines if the patient's level or degree ofappetite or hunger is greater than a first threshold value but less thanor equal to a second threshold value. In some embodiments, the first andsecond threshold values are 0 and 5.5 respectively on a scale of 0 to10. If the patient's degree of appetite or hunger falls between thefirst and second threshold values, the members of the social networkgroup or affinity group and/or the online coaching service may respondwith a first intervention, at step 5714 a. In some embodiments, thefirst intervention may comprise encouraging and appreciativepre-recorded messages such as videos, GIFs (Graphics InterchangeFormat), text based messages and/or emojis from the members of thesocial network group or affinity group and/or the online coachingservice. In some embodiments, the first intervention includespre-recorded coaching instructions from members of the social networkgroup or affinity group and/or the online coaching service to assist thepatient in maintaining dietary compliance. In some embodiments, thefirst intervention may include displaying the patient's own appetiteprofile on the patient's client or control device.

At step 5716 a, the HMA determines if the patient's level or degree ofappetite or hunger is greater than the second threshold value but lessthan or equal to a third threshold value. In some embodiments, thesecond and third threshold values are 5.5 and 8.5 respectively on ascale of 0 to 10. If the patient's degree of appetite or hunger fallsbetween the second and third threshold values, the members of the socialnetwork group or affinity group and/or the online coaching service mayrespond with a second intervention, at step 5718 a. In some embodiments,the second intervention comprises pre-recorded messages such as videos,GIFs, text based messages and/or emojis that are skewed towards beingexcoriating and perhaps portraying the consequential hazards of notcontrolling appetite or hunger. The members of the social network groupor affinity group and/or the online coaching service may also recommendother measures such as rescue sessions, modified stimulation parametersfor the patient and/or coaching instructions to assist the patient inachieving dietary compliance.

At step 5720 a, the HMA determines if the patient's level or degree ofhunger or appetite is greater than the third threshold value and lessthan or equal to a fourth threshold value. In some embodiments, thethird and fourth threshold values are 8.5 and 10, respectively, on ascale of 0 to 10. If the patient's degree of appetite or hunger fallsbetween the third and fourth threshold values, the members of the socialnetwork group or affinity group and/or the online coaching service mayrespond with a third intervention, at step 5722 a. The patient's degreeof appetite falling between the third and fourth threshold values isconstrued as a level where the patient needs immediate help andintervention. In some embodiments, in the third intervention a member ofthe social network group or affinity group and/or a coach person,dietician or caregiver (instead of an automated online coaching service,for example) may call up and/or message the patient in real-time.

Feedback, coaching and advisory responses may additionally oralternatively be elicited, in some embodiments, by enabling the patientto manually share the plurality of data (shareable data) or a sub-setthereof, with one or more users other than the members of social networkgroup or affinity group, via communication channels such as, but notlimited to, Facebook Messenger, WhatsApp or any other communicationapplication known to persons of ordinary skill in the art.

It should be appreciated that the first, second, third and fourththreshold values may be different depending at least upon a scale fordefining the degree of appetite or hunger. Also, in some embodiments,the interventions may be based on a single threshold value. Thus, in analternate series of steps, at step 5712 b, the HMA determines if thepatient's level or degree of appetite or hunger is above a thresholdvalue. In some embodiments, the threshold value is 5.5 on a scale of 0to 10. If the degree of appetite or hunger falls below the thresholdvalue, the HMA, at step 5714 b, does not cause any intervention to bedelivered to the patient. However, if the degree of appetite or hungerfalls above the threshold value, the HMA, at step 5716 b enables themembers of the social network group or affinity group and/or the onlinecoaching service to respond with an intervention. In variousembodiments, the intervention comprises coaching instructions to assistthe patient in achieving dietary compliance, pre-recorded messages(videos, GIFs, text based messages and/or emojis) from one or moreindividuals connected with the patient within the social network and/orreal-time messages (real-time calling and or real-time videos, GIFs,text based messages and/or emojis) from one or more members of thesocial network group or affinity group and/or the online coachingservice.

In another alternate series of steps and in accordance with aspects ofthe present specification, the type and nature of feedback, coaching andadvice, provided by the online coaching service and/or the coach person,dietician or caregiver, is based on at least one of the level or degreeof hunger or appetite, time of day, number of steps taken (that is,exercise score/level), caloric intake taken, and location of patient.For example, at step 5712 c, the patient's reported high level or degreeof hunger or appetite (of more than a predefined threshold value—such as5.5) may be flagged as ‘chronic’ if the patient frequently reports thehigh level at a particular time of the day, say, after workouts at agym. Accordingly, the automated online coaching service detects such‘chronic’ correlations and advises the patient, at step 5714 c, toproactively stimulate at or near the particular time of the day. Asanother example, at step 5712 d, the patient's reported high level ofhunger or appetite (of more than the predefined threshold value—such as5.5) may be flagged as ‘acute’ if the high level reported by the patientis more random and less frequent. Accordingly, at step 5714 d, theautomated online coaching service response is different such as, but notlimited to, distracting the patient (away from the psychological pangsof hunger), reminding the patient of his goals and health hazards offalling prey to the hunger pangs, and/or triggering a media presentationto the patient. The media presentation could be pre-stored GIFs, audioand/or video giving encouragement, for example. The media could be ofthe patient himself, a friend or a loved one requesting, encouraging andreminding the patient to overcome obesity and/or meet the targetedweight.

In some embodiments, the HMA processes the data indicative of thepatient's degree of appetite to determine when, at a future time, thepatient will be hungry and transmits a signal to the electrical dermalpatch positioned on the patient's skin based upon said future time (asdiscussed earlier in the specification with reference to Big Dataanalytics).

At step 5724, the patient is enabled to reply to the interventions oradvisory responses or feedback of the members of the social networkgroup and/or the online coaching service to either thank them for thefeedback or to update them with the patient's medical condition and,say, improved plurality of data related to the patient's medicalcondition.

In various embodiments, the titration or modulation of the therapy isdirected towards moderating or completely terminating the stimulationtherapy in order to reduce and/or prevent further occurrence of nauseaand/or dyspepsia events. As discussed earlier in the specification, onoccurrence of an actionable nausea and/or dyspepsia event, the HealthManagement application may modify an existing stimulation protocol, forexample may recommend switching a current baseline stimulation protocolto a mild stimulation protocol. Additionally or alternatively, thestimulation continuity profile may be switched to a step-down profile.Still further, the Health Management application may recommend pausingthe stimulation sessions for one or more days before restarting with astep-down stimulation protocol. For example, in one embodiment, anysingle nausea and/or dyspepsia event at an intensity of 10 on the VASscale will immediately cause all subsequent therapy sessions to bestopped and the user prompted to call their physician. In anotherembodiment, for example, any cumulative actionable VAS score of 15 inthe same week—that is, a score of a 4, and a 5 and a 6 would, incombination, cause the Health Management application to shut downtherapy. In yet another embodiment, any actionable cumulative score inthe same week greater than 10 would cause the Health Managementapplication to reduce the reducing baseline therapy sessions from 30 to15 minutes each. In this embodiment, if the frequency of such actionablenausea and/or dyspepsia events continue the therapy is terminated.

While the therapeutic efficacy of the device has been described above interms of modulating levels of appetite, hunger, satiety, satiation,caloric intake, and/or weight loss, it may also be described in terms ofdelaying gastric emptying time or increasing gastric retention time.Applying the treatment protocols described above, a patient with a BMIof 25 or greater adheres an electrical dermal patch to his or herepidermal layer such that an electrical field, generated by theelectrical dermal patch via a plurality of stimulation sessions,directly contacts at least one of the patient's C5, C6, C7, C8, T1, T2,T3, T4, T5, T6, T7, T8, T9, T10, T11, and T12 frontal and lateraldermatomes and penetrates a range of 0.1 mm to 25 mm through thepatient's epidermal layer. The electrical dermal patch has a housingwith a base surface, where the base surface is defined by a total basesurface area, where at least a portion of the total base surface area isadapted to be adhered to the epidermal layer of the patient, and wherethe total base surface area is less than 10 in², has a controllerpositioned within the housing, has at least one electrode positionedwithin the housing and adapted to be in electrical contact with saidpatient's epidermal layer, and has a pulse generator positioned withinthe housing and in electrical communication with the controller and saidat least one electrode.

It should further be appreciated that, preferably, the electro-dermalpatch comprises a transceiver in communication with at least one of saidcontroller and pulse generator and a plurality of programmaticinstructions, stored in a non-transient computer readable memory of adevice physically separate from said electrical dermal patch, wherein,when executed, the programmatic instructions acquire patient status datafrom an external device (such as a mobile phone running a healthmanagement application), generate a modulation signal based upon saidpatient status data, and wirelessly transmit said modulation signal fromthe device to the transceiver, wherein said modulation signal comprisesdata for modulating at least one of said plurality of stimulationparameters. As discussed throughout this specification, the patientstatus data comprises at least one of the patient's hunger, thepatient's hunger appetite, the patient's satiety level, the patient'ssatiation level, and a degree of well-being being experienced by thepatient. The programmatic instructions acquire a first stimulationprotocol and use the first stimulation protocol to generate themodulation signal. The programmatic instructions acquire a secondstimulation protocol, wherein said second stimulation protocol isdifferent from the first stimulation protocol, and, using said secondstimulation protocol, generate a second modulation signal, wherein saidsecond modulation signal comprises data for modulating at least one ofthe plurality of stimulation parameters. The electrical dermal patch isconfigured to use the second modulation signal to modify at least one ofthe first pulse width, the first pulse amplitude, the first pulsefrequency, the first pulse shape, the first duty cycle, the firstsession duration, and the first session frequency to yield a secondpulse width, a second pulse amplitude, a second pulse frequency, asecond pulse shape, a second duty cycle, a second session duration, or asecond session frequency. At least one of the second pulse width isdifferent from the first pulse width, the second pulse amplitude isdifferent from the first pulse amplitude, the second pulse frequency isdifferent from the first pulse frequency, the second pulse shape isdifferent from the first pulse shape, the second duty cycle is differentfrom the first duty cycle, the second session duration is different fromthe first session duration, and the second session frequency isdifferent from the first session frequency.

Operationally, the pulse generator is configured to generate a pluralityof stimulation sessions, wherein each of said plurality of stimulationsessions comprises a plurality of electrical pulses and wherein each ofsaid plurality of electrical pulses is defined by a plurality ofstimulation parameters, said plurality of stimulation parameters beingdefined such that, after applying at least one of said plurality ofstimulation sessions to the epidermal layer of the patient within 90minutes of said patient consuming a meal, a post-prandial time to empty50% of the patient's stomach contents increases by at least 5% relativeto a post-prandial time to empty 50% of the patient's stomach contentswithout applying at least one of said plurality of stimulation sessions.In other embodiments, it should be appreciated that at least one of saidplurality of stimulation sessions may be applied to the epidermal layerof the patient within 3 hours, 2.5 hours, 2 hours, 1.5 hours, 1 hour,0.5 hours or any increment therein, of consuming a meal. In the examplesprovided herein, a time period of 90 minutes is used, however, anyincrement of time as listed above may be used.

It should be appreciated that, in some embodiments, systems of thepresent specification are used to generate real-time interventions inresponse to a patient's degree of appetite and include an electricaldermal patch and at least one plurality of programmatic instructionsstored in a non-transient memory in a client device separate from theelectrical dermal patch. In some embodiments, the electrical dermalpatch comprises a housing, a controller positioned within the housing,at least one electrode positioned in physical communication with thehousing and adapted to be in electrical contact with the patient's skin,and a pulse generator positioned within the housing and in electricalcommunication with the controller and the at least one electrode. Thepulse generator is configured to generate a plurality of stimulationsessions comprising a plurality of electrical pulses defined bystimulation parameters as discussed in the present specification. Insome embodiments, the system includes a first plurality of programmaticinstructions, a second plurality of programmatic instructions, and athird plurality of programmatic instructions. The first plurality ofprogrammatic instructions is stored in a non-transient memory in aclient device separate from the electrical dermal patch, and, whenexecuted, is adapted to cause the client device to generate a prompt tothe patient to input data indicative of the patient's degree of appetitevia a microphone or a display of said client device. The secondplurality of programmatic instructions is stored in a non-transientmemory in the client device or another device separate from theelectrical dermal patch, and, when executed, determines an appetitepattern of the patient based upon said inputted data. The thirdplurality of programmatic instructions is stored in a non-transientmemory in the client device or another device separate from theelectrical dermal patch, and, when executed, determines an interventionand generates said intervention based on the appetite pattern.

It should further be appreciated that, in some embodiments, systems ofthe present specification are used to generate real-time interventionsin response to a patient's degree of appetite and include an electricaldermal patch and at least one plurality of programmatic instructionsstored in a non-transient memory in a client device separate from theelectrical dermal patch. In some embodiments, the electrical dermalpatch comprises a housing, a controller positioned within the housing,at least one electrode positioned in physical communication with thehousing and adapted to be in electrical contact with the patient's skin,and a pulse generator positioned within the housing and in electricalcommunication with the controller and the at least one electrode. Thepulse generator is configured to generate a plurality of stimulationsessions comprising a plurality of electrical pulses defined bystimulation parameters as discussed in the present specification. Insome embodiments, the system includes a first plurality of programmaticinstructions and a second plurality of programmatic instructions. Thefirst plurality of programmatic instructions is stored in anon-transient memory in a client device separate from the electricaldermal patch, and, when executed, communicates with said electricaldermal patch and prompts the patient to input data indicative of thepatient's degree of appetite via a microphone or display of said clientdevice. The second plurality of programmatic instructions is stored in anon-transient memory in the client device or another device separatefrom the electrical dermal patch, and, when executed, receives the dataindicative of the patient's degree of appetite, processes the dataindicative of the patient's degree of appetite to develop predictions ofwhether the patient's degree of appetite will be above or below athreshold value in a future time window, does not generate anyintervention in the future time window if the patient's degree ofappetite is expected to be below the threshold value, and causes a firstintervention to be generated in the future time window if the patient'sdegree of appetite is expected to be above the threshold value.

The present invention may be defined by a plurality of differenttherapeutic endpoints related to the delay of gastric emptying time orincrease in gastric retention time, including:

-   -   Defining the plurality of stimulation parameters such that,        after applying at least one of said plurality of stimulation        sessions to the epidermal layer of the patient (preferably        within 90 minutes of said patient consuming the meal), the        post-prandial time to empty 95% of the patient's stomach        contents increases by at least 5% minutes relative to the        post-prandial time to empty 95% of the patient's stomach        contents without applying at least one of said plurality of        stimulation sessions.    -   Defining the plurality of stimulation parameters such that,        after applying at least one of said plurality of stimulation        sessions to the epidermal layer of the patient (preferably        within 90 minutes of said patient consuming the meal), a        patient's gastric emptying time is delayed by at least 1%,        relative to the patient's gastric emptying time before        stimulation.    -   Defining the plurality of stimulation parameters such that,        after applying at least one of said plurality of stimulation        sessions for at least 10 minutes of continuous stimulation to        the epidermal layer of the patient (preferably within 90 minutes        of said patient consuming the meal), a patient's gastric        emptying time is delayed by at least 5 minutes, relative to the        patient's gastric emptying time before stimulation.    -   Defining the plurality of stimulation parameters such that,        after applying at least one of said plurality of stimulation        sessions to the epidermal layer of the patient (preferably        within 90 minutes of said patient consuming the meal), a        patient's gastric emptying time is delayed by at least 10        minutes, relative to the patient's gastric emptying time before        stimulation.    -   Defining the plurality of stimulation parameters such that,        after applying at least one of said plurality of stimulation        sessions for at least 40 minutes of continuous stimulation to        the epidermal layer of the patient (preferably within 90 minutes        of said patient consuming the meal), a patient's gastric        emptying time is delayed by at least 20 minutes, relative to the        patient's gastric emptying time before stimulation.    -   Defining the plurality of stimulation parameters such that,        after applying at least one of said plurality of stimulation        sessions for at least 90 minutes of continuous stimulation to        the epidermal layer of the patient (preferably within 60 minutes        of said patient consuming the meal), a patient's gastric        emptying time is delayed by at least 24 minutes, relative to the        patient's gastric emptying time before stimulation.    -   Defining the plurality of stimulation parameters such that,        after applying at least one of said plurality of stimulation        sessions to the epidermal layer of the patient (preferably        within 90 minutes of said patient consuming the meal), a        patient's gastric emptying time (of 50% of stomach solids        content) is delayed by at least 15 minutes, relative to the        patient's gastric emptying time before stimulation.    -   Defining the plurality of stimulation parameters such that,        after applying at least one of said plurality of stimulation        sessions to the epidermal layer of the patient (preferably        within 90 minutes of said patient consuming the meal), a        patient's gastric emptying time (of 50% of stomach solids        content) is delayed by at least 25 minutes, relative to the        patient's gastric emptying time before stimulation.    -   Defining the plurality of stimulation parameters such that,        after applying at least one of said plurality of stimulation        sessions to the epidermal layer of the patient (preferably        within 90 minutes of said patient consuming the meal), a        patient's gastric emptying time (of 50% of stomach solids        content) is delayed by at least 10%, relative to the patient's        gastric emptying time before stimulation.    -   Defining the plurality of stimulation parameters such that,        after applying at least one of said plurality of stimulation        sessions for at least 5 minutes of continuous stimulation to the        epidermal layer of the patient (preferably within 90 minutes of        said patient consuming the meal), a patient's post prandial        gastric emptying time (of 50% of stomach solids content) is        delayed by at least 5 minutes.    -   Defining the plurality of stimulation parameters such that,        after applying said plurality of stimulation sessions to the        epidermal layer of the patient (preferably within 90 minutes of        said patient consuming the meal), with a weekly duty cycle of at        least 1%, a patient's post prandial gastric emptying time (of        50% of stomach solids content) is delayed by at least 5 minutes.    -   Defining the plurality of stimulation parameters such that,        after applying at least one of said plurality of stimulation        sessions to the epidermal layer of the patient (preferably        within 90 minutes of said patient consuming the meal), a        patient's gastric retention (that is, retention of solid gastric        contents) is increased by 50%, 120 minutes after food intake.    -   Defining the plurality of stimulation parameters such that,        after applying at least one of said plurality of stimulation        sessions to the epidermal layer of the patient (preferably        within 90 minutes of said patient consuming the meal), an amount        or rate of a patient's gastric motility is reduced in a range of        5 to 10% relative to the amount or rate of the patient's gastric        motility before stimulation.    -   Defining the plurality of stimulation parameters such that,        after applying at least one of said plurality of stimulation        sessions to the epidermal layer of the patient (preferably        within 90 minutes of said patient consuming the meal), a        patient's gastric accommodation or distention is impaired by at        least 15%, relative to the patient's gastric accommodation or        distention before stimulation.    -   Defining the plurality of stimulation parameters such that,        after applying at least one of said plurality of stimulation        sessions to the epidermal layer of the patient (preferably        within 90 minutes of said patient consuming the meal), a        patient's gastric retention increases by 5% relative to the        patient's gastric retention before applying said at least one of        said plurality of stimulation sessions.    -   Defining the plurality of stimulation parameters such that,        after applying at least one of said plurality of stimulation        sessions to the epidermal layer of the patient (preferably        within 90 minutes of said patient consuming the meal), the        patient's gastric retention increases relative to the patient's        gastric retention before applying said at least one of said        plurality of stimulation sessions.    -   Defining the plurality of stimulation parameters such that,        after applying at least one of said plurality of stimulation        sessions for at least 5 minutes to the epidermal layer of the        patient (preferably within 90 minutes of said patient consuming        the meal), a post-prandial time to empty 50% of the patient's        stomach contents increases by at least 5 minutes relative to a        post-prandial time to empty 50% of the patient's stomach        contents without applying at least one of said plurality of        stimulation sessions.    -   Defining the plurality of stimulation parameters such that,        after applying at least one of said plurality of stimulation        sessions for at least 5 minutes to the epidermal layer of the        patient (preferably within 90 minutes of said patient consuming        the meal), the post-prandial time to empty 95% of the patient's        stomach contents increases by at least 5 minutes relative to the        post-prandial time to empty 95% of the patient's stomach        contents without applying at least one of said plurality of        stimulation sessions.    -   Defining the plurality of stimulation parameters such that,        after applying at least one of said plurality of stimulation        sessions to the epidermal layer of the patient, the patient's        appetite or hunger decreases relative to the patient's appetite        or hunger before applying said at least one of said plurality of        stimulation sessions and a nausea level of the patient does not        increase relative to the patient's nausea level before applying        said at least one of said plurality of stimulation sessions.    -   Defining the plurality of stimulation parameters such that,        after applying at least one of said plurality of stimulation        sessions for at least 5 minutes to the epidermal layer of the        patient (preferably within 90 minutes of the patient consuming a        meal), a post-prandial time to empty 50% of the patient's        stomach contents increases by at least 5% relative to a        post-prandial time to empty 50% of the patient's stomach        contents without applying at least one of said plurality of        stimulation sessions.    -   Defining the plurality of stimulation parameters such that,        after applying at least one of said plurality of stimulation        sessions to the epidermal layer of the patient (preferably        within 90 minutes of the patient consuming a meal), a        post-prandial time to empty 25%, 50%, 75%, or 95% of the        patient's stomach contents increases by at least 5%, 10%, 15%,        20%, 25% or 50%, or any increment therein, relative to a        post-prandial time to empty an equivalent amount of the        patient's stomach contents without applying at least one of said        plurality of stimulation sessions.    -   Defining the plurality of stimulation sessions to achieve any of        the aforementioned therapeutic objectives such that the total        cumulative stimulation in a given day is more than 5 minutes but        less than 60 minutes.    -   Defining the plurality of stimulation sessions to achieve any of        the aforementioned therapeutic objectives such that at least a        portion of the stimulation in a given day, preferably a majority        of the cumulative stimulation in a given day, is applied after 2        pm.

It should be appreciated that, unlike the prior art which attempted toaffect gastric emptying time using the direct stimulation of themusculature of the gastrointestinal tract, Applicant's electrical pulsesare defined such that 1) the generated electrical field does notdirectly contact the patient's gastrointestinal tract and does notcontact the patient's vagus nerve, 2) each of the electrical pulses aredefined by a maximum pulse width of 1 ms, preferably less than 1 ms,preferably less than 0.5 ms, preferably below 0.2 ms, 3) the generatedelectrical field is configured to activating the patient'ssomatovisceral reflex and not stimulate parasympathetic nerves,autonomic nerves, the musculature of the gastrointestinal tract,including the stomach, esophagus, duodenum, small intestine, or largeintestine, or smooth muscle in general, and 4) the electrical field doesnot penetrate more than 20 mm through the patient's skin.

Furthermore, the electrical pulses are delivered through a specializedelectro-dermal patch device that has a constrained footprint (less than10 in²), not requiring two disparately positioned electrodes.Preferably, the device has two electrodes with the first electrode andsecond electrode being separated by a distance of less than 20 mm andhas an adhesive layer positioned on the portion of the total basesurface area, wherein, when the adhesive layer of the electrical dermalpatch is adhered to the patient's epidermal layer, the electrical dermalpatch has an average minimum peel strength in a range of 1.0 to 2.1newtons.

Gastric emptying time may be measured through a plurality of differentways and the therapeutic endpoints described above are equallyapplicable regardless of what measurement technique is applied. Forexample, the therapeutic endpoints described above may be evaluatedusing gastric emptying scintigraphy (GES) that uses radionuclides tomeasure gastric emptying time. After radiolabeling the solid or liquidcomponent of a meal, the gastric counts measured by scintigraphycorrelate directly with the volume of the meal remaining without theneed for geometric assumptions about the shape of the stomach.Alternative tests include breath testing and acetaminophen absorption.Breath testing, which assumes normal small bowel absorption andpulmonary function, indirectly measures gastric emptying, as gastricemptying is the rate-limiting step in the processing and excretion of13C-octanoic acid. Exemplary protocols for measuring gastric emptyingrates may be found in “Consensus Recommendations for Gastric EmptyingScintigraphy: A Joint Report of the American Neurogastroenterology andMotility Society and the Society of Nuclear Medicine”, Abell et al.,American Journal of Gastroenterology, 2007, pages 753-763, which isherein incorporated by reference.

Will Power Conservation

In accordance with an aspect of the present specification, it isrecognized that an ‘urge to eat’ is a function of hunger (a physicalneed) and appetite (a psychological need). It should therefore beappreciated that the EDP system of the present specification dampens theuser's ‘urge to eat’ so that the user does not has to exert, waste orspend too much ‘will power’ to comply with diets, exercises or any othertherapy related regimen. In other words, the EDP system of the presentspecification enables users to conserve their will power and improveconservation and therefore reserves of will power as the stimulationtherapy progresses.

In accordance with some embodiments, will power is determined orcomputed as an inverse function of hunger level or score. In otherwords, as the user's hunger score decreases his will power conservedincreases while as the hunger score increases the user's will power isspent or wasted. Accordingly, the HMA presents GUIs showing vertical orhorizontal bar graphs, such as in the form of light bar VASs, or anyother graphical form evident to persons of ordinary skill in the art, toillustrate the user's hunger score trend over a predefined period oftime as well as the user's will power conservation status or trend overthe same predefined period of time. In some embodiments, the user'shunger scores over the predefined period of time are togetherrepresented as an aggregate hunger score for the period of time.Similarly, the user's will power conservation level or score isdetermined or computed as an inverse function of the aggregate hungerscore for the period of time. FIG. 53A shows a will power VAS 5305 wherethe colored bar portion 5306 is representative of the amount or level ofwill power conserved as a result of low or decreased levels of hungerexperienced by the user. On the other hand, FIG. 53B shows a will powerVAS 5310 where the colored bar portion 5312 represents reduced level oramount of will power conserved as a result of high or increased levelsof hunger experienced by the user. In other words, VAS 5310 conveys thatthe level or amount of will power wasted is high compared to the VAS5305. Thus, the user's will power conservation status is determined anddisplayed based upon the user's hunger profile or map over a predefinedperiod of time.

In accordance with some embodiments, will power is determined orcomputed as a composite function of two sub-parameters such as dietarywill power and exercise will power. In accordance with variousembodiments, dietary will power is computed as an inverse function ofhunger levels or as a directly proportional function of dietarycompliance, while exercise will power is computed as a directlyproportional function of amount or level of exercise or activity of theuser. FIGS. 54A, 54B illustrate dietary will power and exercise willpower levels displayed as respective vertical piston bar graphs 5405,5410 in accordance with an embodiment. The piston 5412 for the exercisewill power level 5410 rise the more the user exercises. The piston 5407for the dietary will power levels 5405 rise the more the user complieswith his dietary plan (or the lower the hunger levels are). Thus,depending upon the levels of dietary compliance and exercising, thedietary and exercise will powers are affected and the two piston bars5405, 5410 accordingly move up or down.

In accordance with some embodiments, dietary will power is determined orcomputed as a directly proportional composite function of dietarycompliance and hunger control or appetite control. The dietary willpower status or level is then displayed as a vertical or horizontal bargraph, for example. In various embodiments, the user's score includes atleast the amount of calories and the type of calories consumed and isdisplayed as a vertical bar graph. Similarly, the hunger control orappetite control score is displayed as another vertical bar graph. Inaccordance with an aspect, if the user's hunger is high and dietarycompliance is low, the dietary will power graph is displayed to be in ared zone and/or the EDP flashes red color via LEDs. As hunger moves downand dietary compliance increases, the dietary will power graph isdisplayed to be in a yellow zone and/or the EDP flashes yellow color. Ashunger moves all the way down and dietary compliance is high the dietarywill power graph is displayed to be in a green zone and/or the EDPflashes green color.

In accordance with an aspect of the present specification, users areencouraged and rewarded for achieving and maintaining their will powerlevels, reserves or conservation high, such as by achieving the yellowor green zones, for example. In various embodiments, the rewards are inthe form of points, badges, and/or emojis. The users are allowed toshare their rewards, such as badges or points, within their socialnetworks. In some embodiments, the users are allowed to redeem theirrewards for discounts or, partial or complete waver of their therapysubscription fees and/or earn coupons for other services.

In accordance with some embodiments, will power levels, reserves orconservation is computed or determined as an inverse function of an‘urge to eat’ profile or map of the user. In accordance with someembodiments, the ‘urge to eat’ profile is itself defined as a functionof at least one of: total consumption of calories (which is one exampleof a daily diet plan is less than 1200 calories), type of caloriesconsumed (for example, a diet composition of carbs to proteins in theratio of 20:80) and the timing of meals (for example, ideally eating atmeal times). Thus, the greater the ‘urge to eat’ the more is the willpower wasted or spent and therefore the less is the will power conservedor reserved.

In accordance with still other embodiments, will power levels, reservesor conservation is computed or determined as a composite function of atleast two of a plurality of parameters such as, but not limited to,total consumption of calories (which in one example of a daily diet planis less than 1200 calories), type of calories consumed (for example, adiet composition of carbs to proteins in the ratio of 20:80), the timingof meals (for example, ideally eating at meal times), exercise oractivity levels (an ideal goal being 10,000 steps for example) andweight (ideally being, for example, within say 5% of a target weight).

In yet other embodiments, will power levels, reserves or conservation iscomputed or determined as a composite function of hunger scoreimprovement, dietary compliance and exercise levels. In variousembodiments, the composite will power level or score is ratedperiodically such as, daily or weekly. In accordance with an aspect, todetermine the composite will power levels or scores, the user isperiodically presented with VAS light bars to enable the user to: ratehis success in maintaining a certain diet plan, such as that of a dailyconsumption of 1200 calories, rate his success in limiting out-of-mealplan snacking, rate his success in eating healthy foods, and rate hissuccess in controlling hunger. Additionally, determination of thecomposite will power levels or scores involves automatic inputs such as,bonus points earned for each hunger rescue bolus, bonus points earnedfor exercising or activity, bonus points earned for filling out thedaily diary, bonus points earned for favorable daily weight changeand/or bonus points earned for positive coaching of other patientswithin the user's social network group, for example.

It should be appreciated that the user's will power levels, reserves orconservation can be computed or determined as a function of one or moreunderlying parameters as described above. In alternate embodiments, theuser is presented with a light bar VAS to assess the user's dietary willpower on a daily, weekly or any other suitable periodic basis. Theuser's will power levels, scores, reserves or conservation is displayedto the user in a plurality of graphs such as, but not limited to,vertical or horizontal bar graphs, piston bar graphs, VAS light bars,gas tank like graphs, hour glass illustrations or any other suitabledisplay advantageously evident to persons of ordinary skill in the art.

In various embodiments, the user's will power levels, scores, reservesor conservation is archived throughout the stimulation therapy cycle orperiod to generate the user's will power profile or map. Multiple EDPusers' will power profile or map enables determining an average willpower level or score of a population or group of EDP users. Inaccordance with an aspect, the HMA compares a particular user's willpower level or score with the average will power level or score of arepresentative population or group of EDP users, for a predefined periodof time, to communicate to the user how his will power levels are faringwith reference to the representative population or group of users. Invarious embodiments, the representative population of group of users maybe those of characteristic age, gender, ethnicity, weight, weight lossgoal, body mass index, body fat percentage, and/or race.

In accordance with another aspect of the present specification, theuser's will power level or score also affects the composite, aggregateor collective will power level or score of the social network group,also referred to as an ‘affinity group’, that the user may be a memberof. Affinity groups that share similar health goals (for example, weightloss) benefit a user member in a plurality of ways such as, but notlimited to, enabling sharing of success stories, enabling sharing ofnon-HIPAA information, enabling sharing progress and compareperformance, enabling users to display and share their rewards (points,emojis, badges) earned by achieving high levels of will power, sharingstimulation parameters and/or protocols that lead to better weight loss,improved dietary compliance, higher levels of well-being and increasedlevels of will power conservation.

In other words, an individual user may not only have a personal willpower level or score but may also be associated with a collective willpower level or score of the affinity group that he is a member of. Theaffinity group, in various embodiments, may also strive towards acollective goal associated with will power levels, hunger control,weight loss, and/or dietary compliance. Thus, in some embodiments, ifthe user's will power level rises it improves the collective will powerscore of the affinity group and vice versa. In some embodiments, userswith at least a predefined minimum score for will power levels areallowed to coach other affinity group members. In some embodiments, ahigh level or score, above a predefined threshold, for will power of auser can result in one or more rewards such as, but not limited to,reduction of a monthly stimulation therapy fee for the user, freecoupons for other services (such as a discounted fee coupon for entry ormembership to a gym), free or discounted personalized concierge service,coaching or assistance associated with the EDP device and HealthManagement application of the present specification. As another example,if the affinity group has a collective goal of, say, achieving 5% totalbody weight loss, a member user who achieves the goal or is close toachieving the goal may receive encouragement emojis as group supportfrom the group members. To support and encourage the group members, thesuccessful members or high achievers are also enabled to share theirtherapy credentials such as, but not limited to, diet plans, exerciseregimes, stimulation parameters, protocols and will power levels withthe group. Again, each time a user triggers a rescue session or bolusand/or fills out his daily diary—he is rewarded bonus will power points,for example, and this event is automatically communicated to othermembers of the affinity group so that other members can send emojisencouragement to the user.

An online concierge service associated with the EDP device and HealthManagement application of the present specification may access, processand analyze the user's health related information such as, but notlimited to, daily diary entries, a hunger map, a map of daily rescuesessions, dietary compliance, weight trends, exercise data, stimulationprotocol, a dietary plan, will power level or score. In accordance withan aspect, the online concierge service functions as an automated onlinecoaching service to educate patients on various functionalities or usageof the EDP device, such as through step-by-step audio-video demos thatshow the patients how to use the EDP device. In accordance with anotheraspect, the online concierge service may provide interventions in theform of adjusted or modified stimulation parameters, settings andprotocols; modifications to exercising routines, forms, frequency andperiod; and/or adjustments to the user's dietary plan. In accordancewith yet another aspect, the online concierge service would enableautomated or personalized encouragement and advice to the patient (fortheir dietary progress, for example, based on input from their diaries)such as, but not limited to, “you are doing amazingly well compared toyour affinity group—your composite score is X versus Y for the group asa whole and by our calculation you will achieve your weight loss goal ofZ lbs by D date”, “we recommend you add 2000 steps to your dailyroutine”, “you are doing well, your hunger score is down and your weightloss is better than the aggregate weight loss for all users or for youraffinity group”, “you are showing signs of recurring hunger after dinneraround 8:00 pm—we suggest that you eat more protein in your evening mealand apply a rescue stimulation session at 7:30 pm” or any other adviceas would be advantageously evident to persons of ordinary skill in theart.

Thus, in various embodiments, the online concierge or dietary coachservice algorithmically responds to user input with encouragement andrecommendations such as, but not limited to, checking on the user'scorrect usage of the EDP device and compliance with operatinginstructions and daily diary completion, suggesting that the user shouldchange timing of stimulation sessions (for example, around mealtimes) orincrease usage of rescue sessions, suggesting that the user adopt acalorie counting regimen (from an approved list of Apps), suggestingthat the user join an affinity group (from an approved list) for moralsupport, suggesting that the user go to a prepackaged meal substitutionplan (from an approved list, such as, for example Jenny Craig),suggesting that the user exercise more and use a recommended or approvedthird party device with physiological sensors, and suggesting that theuser join an intensive coaching plan from an approved list. Inaccordance with an aspect, the online coaching and recommendationfunction via the concierge service enables supporting, providing andtherefore selling targeted advertisements as an adjunct to variousrecommendations such as, but not limited to, the calorie counting App,prepackaged meal plan, and the third party physiological monitoringdevice.

In various embodiments, status, scores and trends related to collectivegoals of the affinity group are periodically (such as, daily, weekly,bi-weekly, monthly) aggregated and shared among affinity group members,in the form of graphs for example, and may also be compared withindividual member status, scores and trends. The collective goals mayinclude will power levels, hunger scores, weight loss, calorieconsumption, exercise score and/or dietary compliance.

In various embodiments, a user is allowed to subscribe to the dietaryplans, exercise regimes, or stimulation parameters of affinity groupmembers who have attained certain threshold scores (whether thesethreshold scores are wellness or will power scores, for example). Thisencourages affinity group members with high will power scores to getfollowers by enabling the affinity group members to publish theirsuccess credentials such as, but not limited to, diet plans, exerciseregimes, stimulation parameters, protocols and will power levels.

In accordance with various aspects, the user's will power score or levelcan be utilized to participate in games or tournaments such as, forexample, among members of the affinity group. In various embodiments,users can earn points and bonuses corresponding to their achieving aplurality of degrees or levels of will power. In various embodiments, asthe user accumulates points, to earn progressively higher points theuser may be required to not only achieve high levels of will power butalso successfully pass a plurality of filters related to various healthparameters such as, but not limited to, striking a certain percentage ofa weight loss goal, dietary compliance to stay below 1200 Kcal/day,exercise or be active commensurate with 10,000 steps per day. Theaccumulated points will enable the users to win or be eligible for aplurality of rewards at various levels such as, but not limited to,emojis, electronic badges, reduction of a stimulation therapy fee forthe user, free discounted coupons for other services (such as adiscounted fee coupon for entry or membership to a gym or entry to arelevant health or fitness camp), free or discounted personalizedconcierge service, coaching or assistance associated with the EDP deviceand Health Management application of the present specification.

Composite Dietary Performance, Wellness or Treatment Compliance Score

In accordance with various aspects of the present specification, acombined or composite score is determined that is a function of at leastthe following categories or groups of metrics: a) adherence to thestimulation treatment regimen, b) actual dietary and well-beingperformance, and c) effective communication with the TPM and within theaffinity or social networking group. In various embodiments thecomposite score is indicative of how well the patient is complying withthe treatment regimen and therefore how well he is faring in terms ofhis overall health and wellness goal. In various embodiments, thecombined, composite or compliance score is a function of a plurality offactors, such as, but not limited to, whether the patient wears the EDPdevice daily; whether the patient provides or inputs daily diary data,as needed; whether the patient regularly receives the stimulationsession therapies as scheduled (that is, does not miss the scheduledsessions); whether the patient reports calories consumed by recordingactual calories consumed; how well the patient adheres to a restrictedcalories diet (that is the planned diet); type or quality of caloriesconsumed (that is, whether the patient is consuming a healthy diet);whether the patient records his actual weight daily; the patient'sactual daily weight loss; whether the patient uses wearable devices, forexample, a device, with physiological sensors, configured to be worn onthe human body, such as around the wrist, in order to monitor, acquire,record, and/or transmit the physiological data; the patient's actualexercise score or metrics, such as steps taken for example, to determinethe calories expended; the patient's appetite score; sleep quality ofthe patient determined at least on the basis of the number of hours thepatient slept as detected or recorded by the accelerometer orinclinometer included in the EDP device; whether the patient isproactive enough to request rescue sessions when needed (that is, whenfeeling hungry at non-scheduled meal times, for example); howparticipative the patient is within his affinity group and communicativewith his TPM—for example, whether the patient is encouraging otheraffinity group members with emojis and/or whether the patientcommunicates with his TPM in line with a planned or scheduled feedbackcall with his TPM.

In embodiments, the patient is incentivized, rewarded and encouraged forachieving high compliance scores not only as an individual but also incomparison to aggregate compliance score of the affinity group to whichthe patient is associated. In various embodiments, the patient isrewarded through means such as, but not limited to, encouraging orcongratulatory text messages (such as from a celebrity or personality),bonus points, emoticons/emojis, gift certificates or coupons, healthrelated accessories, free or discounted enrolment to health managementprograms (such as Jenny Craig) and gyms. In embodiments, the patient isalso incentivized, rewarded and encouraged if the patient enablesspreading awareness and adoption of the EDP device to other individuals(currently non-users of the EDP device, for example). For example, thepatient is rewarded and encouraged if she invites people on Facebook orWhatsApp, for example, to use the EDP device and/or shares benefits ofthe EDP device.

In embodiments, the HMA provides a rolling summary of the patient'sdaily diary input data (such as appetite, hunger, exercise andwell-being) or the patient's health status data (comprising a level,score or value related to hunger, appetite, exercise, weight,well-being, will-power, urge to eat profile, hunger profile, standardeating and meals profile, actual eating and meals profile, dietary plan,exercise regimen, energy balance, weight changes, glucose data, rescuebolus events, and stimulation induced nausea, dyspepsia, and habituationevents) and uses any one or any combination of these data to create acomposite score indicative of an overall health status or performance ofthe patient.

It should be appreciated that, in various embodiments, the compositescore may be a function of a subset of the plurality of factorsdescribed above. Also, the composite score is determined not only forindividual patients but also aggregated for affinity groups and/or allEDP users to enable a comparison of an individual score against that ofan entire affinity group and/or an entire EDP user community. Inaccordance with an aspect, the composite score of a patient alone orrelative to the composite score aggregated for affinity groups and/orall EDP users is used to titrate or adjust stimulation therapy. Inaccordance with another aspect, the composite score associated withindividual patients and/or associated with the affinity group is sharedwith online automated coaching or concierge service and/or withdesignated care-providers, physicians, coaches or support groups. Suchsharing may automatically trigger online dietary coaching inputs (suchas via telephone calls and/or video conferencing, for example) such as,but not limited to, congratulatory and encouraging remarks or emojis incase of improved composite scores, cautionary remarks and/or dietarycompliance tips including healthy food options in case of laggingcomposite scores.

Therapeutic Objectives

In various embodiments, the systems and methods of the presentspecification employ an electro-dermal patch that providespre-programmed and/or customized stimulation protocols to induce changesin antral and gastric motility to slow passage of food. In variousembodiments, a Health Management application software, as describedabove, provides and/or enables the programming, either pre-programmed orset ‘on demand’ by the patient or medical personnel (in real time), of aplurality of therapeutic goals which are also customizable or adjustablein order to modulate gut hormones, modulate gut microbiota, assessantral and gastric motility, suppress appetite, achieve dietarycompliance, suppress hunger, or elevate fullness, satiation, or satiety.It should be noted herein that any or a plurality of the methods of useor treatment examples provided above may be employed to achieve thetherapeutic objectives.

It should also be noted that the percent changes in value listed beloware represented by the following formula: [(New Value)−(Old Value)]/(OldValue)]. Thus, where a certain parameter is measured in percentage, thepercentage change is reflected by the above formula and not a deltavalue.

The following are a plurality of non-limiting, exemplary goals:

In some embodiments, after at least one stimulation session ordeterminable time period after when stimulation terminates, the rate,level or amount of any patient parameter, as discussed throughout thisspecification is modified relative to the rate, level or amount of thatpatient parameter before stimulation. In one instance, after at leastone stimulation session or determinable time period after whenstimulation terminates, the rate, level or amount of that patientparameter is reduced relative to the rate, level or amount of thatpatient parameter before stimulation. In another instance, after atleast one stimulation session or determinable time period after whenstimulation terminates, the rate, level or amount of that patientparameter is increased relative to the rate, level or amount of thatpatient parameter before stimulation.

In some embodiments, after stimulation terminates, or at least oneminute from when stimulation terminates, the patient experiences adecrease in appetite or hunger by at least 5%.

In some embodiments, after at least one minute from when stimulationterminates or after at least one stimulation session, the patientexperiences a decrease in appetite or hunger such that it is equal to,or less than, 95% of the pre-stimulation appetite or hunger levels.

In some embodiments, after at least one minute from when stimulation isinitiated, the patient experiences a perceptible decrease in appetite orhunger.

In some embodiments, after at least one minute from when stimulation isinitiated, the patient experiences an increase in satiety, satiation orfullness levels by at least 5%.

In some embodiments, after at least one minute from when stimulationterminates or after at least one stimulation session, the patientexperiences an increase in satiety, satiation or fullness levels suchthat it is equal to, or greater than, 105% of the pre-stimulationsatiety, satiation or fullness levels.

In some embodiments, after at least one stimulation session, a patient'scompliance with a target daily caloric intake increases relative to thepatient's compliance with the target daily caloric intake beforestimulation.

In some embodiments, the systems and methods of the presentspecification result in a decrease in the post-stimulation daily caloricintake of a patient relative to a pre-stimulation daily caloric intakeof the patient, wherein the pre-stimulation daily caloric intake is afunction of an amount of calories consumed by the patient over a firstpredefined period of time prior to stimulation, and wherein thepost-stimulation daily caloric intake is a function of an amount ofcalories consumed by the patient over a second predefined period of timeequal in duration to the first predefined period of time, afterstimulation is initiated. For example, the decrease may be quantified asequal to or less than 99% of the pre-stimulation caloric intake, wherethe caloric intake decreases to a range of 600 to 1600 calories,decreases from over 2000 calories per day to less than 2000 calories perday, or decreases from over 1600 calories per day to less than 1600calories per day.

In some embodiments, after at least one stimulation session, an amountor rate of a patient's antral motility, gastric motility, gastricemptying, hunger or appetite level is modified, relative to thecorresponding amount before stimulation.

In some embodiments, after at least one stimulation session, the rate ofa patient's antral motility, gastric motility, or gastric emptying ismodified relative to the rate of the patient's antral motility, gastricmotility, or gastric emptying before stimulation, and preferably therate of a patient's antral motility, gastric motility, or gastricemptying is reduced relative to the rate of the patient's antralmotility, gastric motility, or gastric emptying before stimulation.

In some embodiments, after at least one stimulation session, a patient'sgastric emptying time is delayed by at least 1%, relative to thepatient's gastric emptying time before stimulation.

In some embodiments, after at least 10 minutes of continuousstimulation, a patient's gastric emptying time is delayed by at least 5minutes, relative to the patient's gastric emptying time beforestimulation.

In some embodiments, after at least 20 minutes of continuousstimulation, a patient's gastric emptying time is delayed by at least 10minutes, relative to the patient's gastric emptying time beforestimulation.

In some embodiments, after at least 40 minutes of continuousstimulation, a patient's gastric emptying time is delayed by at least 20minutes, relative to the patient's gastric emptying time beforestimulation.

In some embodiments, after at least 60 minutes of continuousstimulation, a patient's gastric emptying time is delayed by at least 24minutes, relative to the patient's gastric emptying time beforestimulation.

In some embodiments, after at least one stimulation session, a patient'sgastric emptying time is delayed by at least 25 minutes, relative to thepatient's gastric emptying time before stimulation.

In some embodiments, after at least one stimulation session, a patient'spost prandial gastric emptying time (of 50% of stomach solids content)is delayed by at least 5 minutes, wherein the patient has a BMI of 25 ormore.

In some embodiments, after at least one stimulation session, a patient'spost prandial gastric emptying time (of 50% of stomach solids content)is delayed by at least 10 minutes, wherein the patient has a BMI of 25or more.

In some embodiments, after at least 5 minutes of stimulation, apatient's post prandial gastric emptying time (of 50% of stomach solidscontent) is delayed by at least 5 minutes.

In some embodiments, with a weekly duty cycle of at least 1%, apatient's post prandial gastric emptying time (of 50% of stomach solidscontent) is delayed by at least 5 minutes.

In some embodiments, with a weekly duty cycle ranging between 1% to 99%,a patient's post prandial gastric emptying time (of 50% of stomachsolids content) is delayed by at least 5 minutes.

In some embodiments, after at least one stimulation session, a patient'sgastric retention (that is, retention of solid gastric contents) isincreased by 50%, 120 minutes after food intake, wherein the patient hasa BMI of 25 or more.

In some embodiments, after at least one stimulation session, an amountor rate of a patient's gastric or antral motility is reduced in a rangeof 8 to 10% on a logarithmic scale, relative to the amount or rate ofthe patient's gastric or antral motility before stimulation.

In some embodiments, after at least one stimulation session, a patient'sgastric accommodation or distention is impaired by at least 15%,relative to the patient's gastric accommodation or distention beforestimulation.

In some embodiments, after at least one stimulation session, a patient'sglucagon-like peptide 1 (GLP-1) is reduced by at least 20%, relative tothe patient's glucagon-like peptide 1 (GLP-1) before stimulation.

In some embodiments, a patient's glucagon-like peptide 1 (GLP-1), in afirst state, is greater than the glucagon-like peptide 1 (GLP-1) in asecond state, wherein the first state is defined by a first area underthe curve (AUC) corresponding to a pre-stimulation glucagon-like peptide1 (GLP-1) and the second state is defined by a second AUC correspondingto a post-stimulation glucagon-like peptide 1 (GLP-1), and wherein thefirst AUC differs from the second AUC by at least 10%, therebyrepresenting a decrease in the glucagon-like peptide 1 (GLP-1) of thepatient.

In some embodiments, a patient's appetite or hunger level, in a firststate, is greater that the appetite or hunger in a second state, whereinthe first state is defined by a first area under the curve (AUC)corresponding to a pre-stimulation appetite or hunger level and thesecond state is defined by a second AUC corresponding to apost-stimulation appetite or hunger level, and wherein the first AUCdiffers from the second AUC by at least 5%, thereby representing adecrease in the appetite or hunger level of the patient.

In some embodiments, a patient's satiety, satiation or fullness level,in a first state, is less than the satiety, satiation or fullness levelin a second state, wherein the first state is defined by a first AUCcorresponding to a pre-stimulation satiety, satiation or fullness leveland the second state is defined by a second AUC corresponding to apost-stimulation satiety, satiation or fullness level, and wherein thefirst AUC differs from the second AUC by at least 5%, therebyrepresenting an increase in the satiety, satiation or fullness level ofthe patient.

In some embodiments, after at least one stimulation session, an amountof a patient's satiety, satiation or fullness levels increases relativeto the corresponding amount before stimulation.

In some embodiments, after at least one stimulation session, a patient'sappetite or hunger level decreases, over a predefined period of time,relative to the patient's appetite or hunger level before stimulationand the patient's nausea and/or dyspepsia level does not increase, overthe predefined period of time, relative to the patient's nausea levelbefore stimulation, wherein the stimulation does not cause the patientto experience a pain sensation.

In some embodiments, after at least one stimulation session, a patient'ssatiety, satiation or fullness level increases, over a predefined periodof time, relative to the patient's satiety, satiation or fullness levelbefore stimulation and the patient's nausea and/or dyspepsia level doesnot increase, over the predefined period of time, relative to thepatient's nausea level before stimulation, wherein the stimulation doesnot cause the patient to experience a pain sensation.

In some embodiments, after at least one stimulation session, a patient'stotal body weight reduces by at least 1% relative to the patient's totalbody weight before stimulation. In some embodiments, after at least onestimulation session, a patient's total body weight reduces by at least3% relative to the patient's total body weight before stimulation. Insome embodiments, after at least one stimulation session, a patient'stotal body weight reduces by at least 1% relative to the patient's totalbody weight before stimulation and the patient's well-being level doesnot reduce more than 5% relative to the patient's well-being levelbefore stimulation. In some embodiments, after at least one stimulationsession, a patient's total body weight reduces by at least 3% relativeto the patient's total body weight before stimulation and the patient'swell-being level does not reduce more than 5% relative to the patient'swell-being level before stimulation.

In some embodiments, after at least one stimulation session, a patient'spre-prandial ghrelin level reduces by at least 1%, and preferably atleast 3%, relative to the patient's pre-prandial ghrelin level beforestimulation. In some embodiments, after at least one stimulationsession, a patient's post-prandial ghrelin level reduces by at least 1%,and preferably at least 3%, relative to the patient's post-prandialghrelin level before stimulation.

In some embodiments, after at least one stimulation session, apost-stimulation ghrelin level of a patient decreases by at least 1%,and preferably at least 3%, relative to a pre-stimulation ghrelin levelof the patient, wherein the pre-stimulation ghrelin level is measuredprior to stimulation and wherein the post-stimulation ghrelin level ismeasured more than ten weeks after the at least one stimulation session.

In some embodiments, a patient's Acyl-Ghrelin and Total Ghrelin, in afirst state, is greater than the Acyl-Ghrelin and Total Ghrelin in asecond state, wherein the first state is defined by a first area underthe curve (AUC) corresponding to a pre-stimulation Acyl-Ghrelin andTotal Ghrelin and the second state is defined by a second AUCcorresponding to a post-stimulation Acyl-Ghrelin and Total Ghrelin, andwherein the first AUC differs from the second AUC by at least 10%,thereby representing a decrease in the Acyl-Ghrelin and Total Ghrelin ofthe patient.

In some embodiments, after at least one stimulation session, the levelof a patient's glucagon-like peptide-1, leptin, serotonin, peptide YY,beta-endorphin levels, resting metabolic rate, and/or cholecystokininincreases relative to the corresponding level of a patient'sglucagon-like peptide-1, leptin, serotonin, peptide YY, beta-endorphinlevels, resting metabolic rate, and/or cholecystokinin beforestimulation.

In some embodiments, after at least one stimulation session, the levelof a patient's triglycerides, cholesterol, lipopolysaccharides, and/ormotilin-related peptide decreases relative to the corresponding level ofa patient's triglycerides, cholesterol, lipopolysaccharides, and/ormotilin-related peptide.

In some embodiments, after at least one stimulation session, a patient'splasma motilin level peak value is reduced by at least 20%, relative tothe patient's plasma motilin level peak value before stimulation.

In some embodiments, a patient's plasma motilin level peak value, in afirst state, is greater than the plasma motilin level peak value in asecond state, wherein the first state is defined by a first area underthe curve (AUC) corresponding to a pre-stimulation plasma motilin levelpeak value and the second state is defined by a second AUC correspondingto a post-stimulation plasma motilin level peak value, and wherein thefirst AUC differs from the second AUC by at least 10%, therebyrepresenting a decrease in the plasma motilin level peak value of thepatient.

In some embodiments, after at least one stimulation session, a patient'sglucagon-like peptide-1 level increases by at least 1%, and preferablyat least 3%, relative to the patient's glucagon-like peptide-1 levelbefore stimulation.

In some embodiments, after at least one stimulation session, a patient'sleptin level increases by at least 1%, and preferably at least 3%,relative to the patient's leptin level before stimulation.

In some embodiments, after at least one stimulation session, a patient'sserotonin level increases by at least 1%, and preferably at least 3%,relative to the patient's serotonin level before stimulation.

In some embodiments, after at least one stimulation session, a patient'speptide YY level increases by at least 1%, and preferably at least 3%,relative to the patient's peptide YY level before stimulation.

In some embodiments, after at least one stimulation session, a patient'speptide YY level decreases by at least 20%, relative to the patient'speptide YY level before stimulation.

In some embodiments, a patient's peptide YY level, in a firstpre-stimulation state, is greater than the peptide YY level in a secondpost-stimulation state, wherein the first pre-stimulation state isdefined by a first area under the curve (AUC) corresponding to apre-stimulation peptide YY level and the second post-stimulation stateis defined by a second AUC corresponding to a post-stimulation peptideYY level, and wherein the first AUC differs from the second AUC by atleast 10%, thereby representing a decrease in the peptide YY level ofthe patient.

In some embodiments, after at least one stimulation session, a patient'sbeta-endorphin level increases by at least 1%, and preferably at least3%, relative to the patient's beta-endorphin level before stimulation.

In some embodiments, after at least one stimulation session, a patient'sresting metabolic rate increases by at least 1%, and preferably at least3%, relative to the patient's resting metabolic rate before stimulation.

In some embodiments, after at least one stimulation session, a patient'scholecystokinin (CCK) level increases by at least 1%, and preferably atleast 3%, relative to the patient's cholecystokinin level beforestimulation.

In some embodiments, after at least one stimulation session, a patient'scholecystokinin level decreases by at least 20%, relative to thepatient's cholecystokinin level before stimulation.

In some embodiments, a patient's cholecystokinin level, in a firstpre-stimulation state, is greater than the cholecystokinin level in asecond post-stimulation state, wherein the first pre-stimulation stateis defined by a first area under the curve (AUC) corresponding to apre-stimulation cholecystokinin level and the second post-stimulationstate is defined by a second AUC corresponding to a post-stimulationcholecystokinin level, and wherein the first AUC differs from the secondAUC by at least 10%, thereby representing a decrease in thecholecystokinin level of the patient.

In some embodiments, after at least one stimulation session, a patient'slipopolysaccharide level reduces by at least 1%, and preferably at least3%, relative to the patient's lipopolysaccharide level beforestimulation. In some embodiments, a reduction in the lipopolysaccharidelevel also reduces metabolic inflammation and insulin resistance.

In some embodiments, after at least one stimulation session, a patient'smotilin-related peptide level reduces by at least 1%, and preferably atleast 3%, relative to the patient's motilin-related peptide level beforestimulation.

In some embodiments, after at least one stimulation session, a patient'striglycerides level reduces by at least 1%, and preferably at least 3%,relative to the patient's triglycerides level before stimulation.

In some embodiments, after at least one stimulation session, a patient'sdegree of glycemia improves by at least 1%, and preferably at least 3%relative to the patient's degree of glycemia before stimulation.

In some embodiments, after at least one stimulation session, a patient'sglycemia (GLU) peak lowers by at least 10%, relative to the patient'sglycemia (GLU) peak before stimulation.

In some embodiments, after at least one stimulation session, anon-diabetic or a non-pre-diabetic patient's glucose is reduced to afasting level of less than 100 mg/dl, reducing the overall chances ofthe patient developing pre-diabetes in the future.

In some embodiments, after at least one stimulation session, apre-diabetic and diabetic patient's postprandial plasma glucoseconcentration is lowered by at least 5%, when measured up to 2 hoursafter a glucose tolerance test.

In some embodiments, after at least one stimulation session, a patient'sglycemic control is improved. In some embodiments, after at least onestimulation session, a patient's glycemic control is modified relativeto the patient's glycemic control before stimulation, and preferably thepatient's glycemic control is increased relative to the patient'sglycemic control before stimulation. In some embodiments, after at leastone stimulation session, the level of hemoglobin A1C decreases by atleast 1%, and preferably at least 3% relative to the patient's level ofhemoglobin A1C before stimulation. In some embodiments, after at leastone stimulation session, the level of hemoglobin A1C decreases by ≥5%relative to the patient's level of hemoglobin A1C before stimulation. Insome embodiments, after at least one stimulation session, the level ofhemoglobin A1C decreases by 0.5% relative to the patient's level ofhemoglobin A1C before stimulation. Because hemoglobin A1C is measured interms of percentage, it should be noted that what is described here isthe percentage change relative to its level before stimulation. Forexample, if the baseline hemoglobin A1C level is measured at 7%, a 5%decrease is calculated as a decrement of 0.35% and therefore a decreasedhemoglobin A1C level of 6.75%.

In some embodiments, after at least one stimulation session, the levelof hemoglobin A1C decreases by at least 1% with a p value of 0.05. Insome embodiments, after at least one stimulation session, the level ofhemoglobin A1C is completely normalized. In some embodiments, after atleast one stimulation session, the level of hemoglobin A1C is ≤7.0%(which equates to 154 mg per dL estimated average glucose in diabetics).

In some embodiments, after at least one stimulation session, a patient'sglucose homeostasis improves by at least 1%, and preferably at least 3%relative to the patient's glucose homeostasis before stimulation.Optionally, glucose homeostasis is quantified by decreasing HOMA-IR(Homeostasis Model Assessment—estimated Insulin Resistance) by ≥5%compared to a baseline HOMA-IR and is calculated as described above withrespect to hemoglobin A1C. In some embodiments, after at least onestimulation session, a patient's level of HOMA-IR decreases by at least4% compared to a level of HOMA-IR prior to applying the stimulationsession. In some T2DM patients, after at least one stimulation session,fasting blood glucose is decreased by 20 mg/dl.

In some embodiments, after at least one stimulation session, the patientexperiences a decrease in a fasting plasma insulin level of ≥5% comparedto a baseline fasting plasma insulin level.

In some embodiments, after at least one stimulation session, the patientexperiences a decrease in a fasting plasma glucose level of ≥5% comparedto a baseline fasting plasma glucose level.

In some embodiments, after at least one stimulation session, a patient'sdegree of insulin resistance is modified relative to the patient'sdegree of insulin resistance before stimulation, and preferably thepatient's degree of insulin resistance is increased relative to thepatient's degree of insulin resistance before stimulation. In someembodiments, after at least one stimulation session, a patient's degreeof insulin resistance improves by at least 1%, and preferably at least3% relative to the patient's degree of insulin resistance beforestimulation.

In some embodiments, after at least one stimulation session, a patient'sbeta cell function of the pancreas is improved relative to the patient'sbeta cell function before stimulation.

In some embodiments, after at least one stimulation session, a patient'slevel of total blood cholesterol decreases by at least 1%, andpreferably at least 3%, relative to the patient's level of total bloodcholesterol before stimulation.

In some embodiments, after at least one stimulation session, acomposition of a patient's gut microbiota is modified relative to acomposition of a patient's gut microbiota before stimulation. In someembodiments, after at least one stimulation session, a composition of apatient's gut microbiota modulates from a first state to a second state,wherein the first state has a first level of bacteroidetes and a firstlevel of firmicutes, wherein the second state has a second level ofbacteroidetes and a second level of firmicutes, wherein the second levelof bacteroidetes is greater than the first level of bacteroidetes by atleast 1%, and preferably at least 3%, and wherein the second level offirmicutes is less than the first level of firmicutes by at least 1%,and preferably at least 3%.

In some embodiments, after at least one session of stimulation session,the patient experiences a modification, and preferably, a perceptibledecrease in appetite or hunger which lasts for at least one day.

In some embodiments, a patient's appetite is reduced by 5% over at least1 day of stimulation therapy.

In some embodiments, after at least one session of stimulation, apatient reports “improved” dietary compliance, wherein dietarycompliance is achieving a daily caloric consumption target. In someembodiments, “improved” dietary compliance is at least 5% closer to adefined or set daily calorie consumption target using the EDP device ofthe present specification.

In some embodiments, a patient has reached a therapeutic goal if theyachieve greater than at least 1%, and more preferably 2%, 5%, 10%, andany increment therein, TWL (Total Weight Loss) or at least 1%, and morepreferably 2%, 5%, 10%, and any increment therein, EWL (Excess WeightLoss) in six months of stimulation therapy.

In some embodiments, a patient has reached a therapeutic goal if theyare able to change their metabolism rate (such as RMR or BMR) by 10%. Insome embodiments, a stimulation therapy is intended to affect at least5% improvement in RMR.

In some embodiments, application of electrical stimulation via the EDPembodiments disclosed herein result in a person having an alteredperception of gastric fullness or emptiness. Specifically, when the EDPtherapy is applied, the stimulation parameters are selected such that,after at least one stimulation session, the perception of gastricfullness or gastric emptiness of the patient increases by at least 1%relative to the perception of gastric fullness or gastric emptiness ofthe patient before stimulation. This may be measured over a single day,week, month or other time period.

In some embodiments, application of electrical stimulation via the EDPembodiments disclosed herein result in a person having increasedexercise output, defined as the amount of calories burned in a giventime period or steps taken in a given time period. Specifically, whenthe EDP therapy is applied, the stimulation parameters are selected suchthat, after at least one stimulation session, exercise output of thepatient increases by at least 1% relative to the exercise output of thepatient before stimulation. This exercise output may be measured over asingle day, week, month or other time period.

It should be appreciated that the exercise output, in some embodiments,may be measured with a third party device (including a third partyapplication software on an external device), with physiological sensors,configured to be worn on the human body, such as around the wrist or thefeet (as smart shoes, for example), in order to monitor, acquire,record, and/or transmit the physiological data, to receive and integrateexercise and weight loss information, along with one or moreelectro-dermal patch devices of the present specification.

In some embodiments, after at least one stimulation session directed toa patient's T7 dermatome, the patient's hepatic gluconeogenesis (glucoseproduction in liver) is lowered by at least 1% thereby improvingglycemia, relative to the patient's hepatic glucogenesis beforestimulation. The patient may be pre-diabetic or diabetic.

In some embodiments, after at least one stimulation session, a patient'sprolactin level increases by at least 5% within a predetermined time,relative to the patient's prolactin level before stimulation.

In some embodiments, after at least one stimulation session, a patient'sdopamine level decreases by at least 5%, relative to the patient'sdopamine level before stimulation.

In some embodiments, after at least one stimulation session, a patient'splasma cytokeratin 18 (CK-18) level decreases by at least 5%, relativeto the patient's plasma cytokeratin 18 (CK-18) levels beforestimulation. It should be appreciated that CK-18 levels correlate withthe magnitude of NAFLD (nonalcoholic fatty liver disease), hepatocyteapoptosis and the presence of NASH (nonalcoholic steatohepatitis) inpatients.

In some embodiments, at the end of a first therapy phase a patient is ata second metabolic or health state, compared to a first metabolic orhealth state at the beginning of the first therapy phase, wherein thesecond metabolic or health state does not deteriorate more than 5% to50%, and any increment therein, during a vacation period (wherein thepatient does not receive any therapy) that extends beyond the end of thefirst therapy phase, and wherein the vacation period is at least equalto the period associated with the first therapy phase.

Achieving Dietary Compliance

In one embodiment, use of the EDP device, in accordance with the methodsdescribed herein, result in patients being able to better comply with apredefined dietary regime, including being better able to restrict dailycaloric intake to a predefined amount, being better able to adhere to adiet designed to maximize particular nutritional components, such asvitamins, minerals, and proteins, and decrease undesirable nutritionalcomponents, such as carbohydrates, fat, and sugars, and being betterable to adhere to a diet designed to have a glycemic index that is equalto or less than a predefined amount. The present specificationfacilitates adhering to dietary objectives for overweight (body massindex of 25-29.9) or obese (body mass index of 30 or greater)individuals, particularly given that willpower alone or even willpowerwith exercise is an ineffectual approach to dietary compliance andeither weight loss or weight management.

Therapeutically, the EDP device can be used in conjunction withpredefined diet plans, comprising a nutritional profile, a set of foods,and/or a maximum number of calories, to ensure that a patient adheres tothe predefined plan.

Therefore, in one embodiment, the present specification enablesincreased dietary compliance. A patient is provided the EDP device,adheres it to his or her epidermal layer, and initiates a stimulationregime. The patient also receives a diet plan, either manually orelectronically into an application executing on an external device, thatdefines a diet plan. The diet plan may establish a maximum daily caloricintake, such as between 600 and 1600 calories, may require a particularnutritional profile, such as a certain number or type of vegetables,proteins, and/or supplements, and/or may require the avoidance ofcertain types of foods, such as carbohydrates, sugars, and/or foods withhigh glycemic indexes. The parameters of the diet plan may be based onreceiving, electronically into an application executing on an externaldevice or manually, an indication of how active the patient is(sedentary, moderately active, active), the patient's gender, thepatient's age, the patient's weight, the patient's height, the patient'spercentage of body fat, and/or the patient's body mass index. As thepatient uses the device and records his or her food consumption, eitherinto the program in the external device in communication with the EDPdevice or into a separate third party program which then transmits theinformation to the program in communication with the EDP device, theprogram in communication with the EDP device determines if the patientis complying with the diet regimen. If the patient is not avoidingcertain types of food, not eating a particular nutritional profile,and/or exceeding the maximum daily caloric intake, the program modulatesstimulation parameters in order to decrease appetite and/or hungerlevels and transmits those modulated stimulation parameters to the EDPdevice, which then increases stimulation strength, duration, and/orfrequency, thereby causing the decrease appetite and/or hunger levelsand enabling the patient to better comply with the diet regimen.Conversely, if the patient is not getting enough calories, the programmodulates stimulation parameters in order to increase appetite and/orhunger levels and transmits those modulated stimulation parameters tothe EDP device, which then decreases stimulation strength, duration,and/or frequency, thereby causing the increase appetite and/or hungerlevels and, again, enabling the patient to better comply with the dietregimen.

In another embodiment, the present specification enables improveddietary management. One substantial problem that physicians and dietprograms have is keeping a patient on the prescribed diet. The presentspecification enables improved dietary management. A third partymanager, such as a physician or health care provider, provides a patientwith the EDP device and programs the EDP device with an initialstimulation regime based upon a prescribed diet plan. The diet plan mayestablish a maximum daily caloric intake, such as in the range of 600 to1600 calories, may require a particular nutritional profile, such as acertain number or type of vegetables, proteins, and/or supplements,and/or may require the avoidance of certain types of foods, such ascarbohydrates, sugars, and/or foods with high glycemic indexes. Theparameters of the diet plan may be based on receiving, electronicallyinto an application executing on an external device or manually, anindication of how active the patient is (sedentary, moderately active,active), the patient's gender, the patient's age, the patient's weight,the patient's height, the patient's percentage of body fat, and/or thepatient's body mass index. As the patient uses the device and recordshis or her food consumption, either into the program in the externaldevice in communication with the EDP device or into a separate thirdparty program which then transmits the information to the program incommunication with the EDP device, the program in communication with theEDP device determines if the patient is complying with the diet regimen.If the patient is not avoiding certain types of food, not eating aparticular nutritional profile, and/or exceeding the maximum dailycaloric intake, the third party manager may modulate stimulationparameters in order to decrease appetite and/or hunger levels andtransmits those modulated stimulation parameters to the EDP device,which then increases stimulation strength, duration, and/or frequency,thereby causing the decrease appetite and/or hunger levels and enablingthe patient to better comply with the diet regimen. Conversely, if thepatient is not getting enough calories, the third party manager maymodulate stimulation parameters in order to increase appetite and/orhunger levels and transmit those modulated stimulation parameters to theEDP device, which then decreases stimulation strength, duration, and/orfrequency, thereby causing the increase appetite and/or hunger levelsand, again, enabling the patient to better comply with the diet regimen.

In another embodiment, the present specification enables improveddietary maintenance and preventing the regaining of weight. Aftermeeting a weight goal, through any of the aforementioned treatmentmethods, the patient's diet plan is adjusted to a new diet planreflecting a weight maintenance, instead of a weight loss, objective.Such a diet plan, which may be received either manually orelectronically into an application executing on an external device, mayestablish a higher maximum daily caloric intake than the previous dietplan, such as between 1600 and 2800 calories, a different nutritionalprofile, and/or less emphasis on avoiding of certain types of foods,such as carbohydrates, sugars, and/or foods with high glycemic indexes.The parameters of the new diet plan may be based on receiving,electronically into an application executing on an external device ormanually, an indication of how active the patient is (sedentary,moderately active, active), the patient's gender, the patient's age, thepatient's weight, the patient's height, the patient's percentage of bodyfat, and/or the patient's body mass index. As the patient uses thedevice and records his or her food consumption, either into the programin the external device in communication with the EDP device or into aseparate third party program which then transmits the information to theprogram in communication with the EDP device, the program incommunication with the EDP device determines if the patient is complyingwith the new diet regimen. If the patient is not avoiding certain typesof food, not eating a particular nutritional profile, and/or exceedingthe new maximum daily caloric intake, the program modulates stimulationparameters in order to decrease appetite and/or hunger levels andtransmits those modulated stimulation parameters to the EDP device,which then increases stimulation strength, duration, and/or frequency,thereby causing the decrease appetite and/or hunger levels and enablingthe patient to better comply with the diet regimen. Conversely, if thepatient is not eating enough calories, the program modulates stimulationparameters in order to increase appetite and/or hunger levels andtransmits those modulated stimulation parameters to the EDP device,which then decreases stimulation strength, duration, and/or frequency,thereby causing the increase appetite and/or hunger levels and, again,enabling the patient to better comply with the diet regimen.

Alternatively, instead of modulating the stimulation parameters if thepatient is not avoiding certain types of food, not eating a particularnutritional profile, and/or exceeding the new maximum daily caloricintake, the program, either in direct communication with the EDP device,a remote server, or a third party application executing on an externaldevice, may change the diet plan itself by increasing or decreasing themaximum daily caloric intake, changing the nutritional profile, and/orchanging what types of foods to avoid.

FIGS. 38A through 38F show charts illustrating how the stimulationtherapy of the present specification affects or modulates a plurality ofpatient variables or parameters such as, weight, BMI (Body Mass Index),appetite, dietary compliance and well-being for a sample of 10 patients.In accordance with an embodiment, the sample of 10 patients, havingweight loss as an objective or goal, were treated with the stimulationtherapy of the present specification over a duration of 4 weeks and thepatients recorded their status on the plurality of variables orparameters throughout the duration of the 4 weeks using their companiondevices. As shown in FIG. 38A, the 10 patients also exercised throughthe duration of 4 weeks and recorded their exercise scores 3805 usingtheir companion devices (as described earlier with reference to FIG.12). The bar graph 3810 shows median exercise scores per week,calculated from the exercise scores of the sample of 10 patients, whilethe line graphs 3815 show exercise scores per week of each of the 10patients. As can be observed from the bar graph 3810, the medianexercise scores 3811, 3812, 3813 improved during the second, third andfourth weeks.

FIG. 38B shows charts illustrating how the weight parameter, for thesample of 10 patients, varied during the course of the 4 weeks, whilethe patients exercised, received stimulation therapy and recorded theirweight using their companion devices (as described earlier withreference to FIG. 15). The bar graph 3820 shows median weights per week,calculated from the weights of the sample of 10 patients, while the linegraphs 3825 show weights per week of each of the 10 patients. As can beobserved from the bar graph 3820, the median weights 3822, 3823, 3824,3826 continued to reduce during the first, second, third and fourthweeks relative to the median weight 3821 at the baseline (that is, priorto receiving stimulation therapy).

FIG. 38C shows charts illustrating how the BMI parameter, for the sampleof 10 patients, varied during the course of the 4 weeks, while thepatients exercised and received stimulation therapy. The bar graph 3830shows median BMI per week, calculated from the BMIs of the sample of 10patients, while the line graphs 3835 show BMIs per week of each of the10 patients. As can be observed from the bar graph 3830, the median BMIs3832, 3833, 3834, 3836 continued to reduce during the first, second,third and fourth weeks relative to the median BMI 3831 at the baseline(that is, prior to receiving stimulation therapy).

FIG. 38D shows charts illustrating how the appetite parameter, for thesample of 10 patients, varied during the course of the 4 weeks, whilethe patients exercised, received stimulation therapy and recorded theirappetite scores 3847 using their companion devices (as described earlierwith reference to FIG. 11). The bar graph 3840 shows median appetitescores per week, calculated from the appetite scores of the sample of 10patients, while the line graphs 3845 show appetite scores per week ofeach of the 10 patients. As can be observed from the bar graph 3840, themedian appetite scores 3842, 3843, 3844, 3846 continued to reduce duringthe first, second, third and fourth weeks relative to the medianappetite score 3841 at the baseline (that is, prior to receivingstimulation therapy).

FIG. 38E shows charts illustrating how the dietary compliance parameter,for the sample of 10 patients, varied during the course of the 4 weeks,while the patients exercised, received stimulation therapy and recordedtheir dietary compliance scores 3857 using their companion devices. Thebar graph 3850 shows median dietary compliance scores per week,calculated from the dietary compliance scores of the sample of 10patients, while the line graphs 3855 show dietary compliance scores perweek of each of the 10 patients. As can be observed from the bar graph3850, the median dietary compliance scores 3852, 3853, 3854, 3856improved during the first, second, third and fourth weeks relative tothe median dietary compliance score 3851 at the baseline (that is, priorto receiving stimulation therapy). The graph 3850 highlights keyadvantages of the wearable and self-administered electro-dermal patchdevice of the present specification, specifically in terms of greaterpatient independence and improved patient compliance to stimulationprotocols, with resultant increased dietary compliance.

FIG. 38F shows charts illustrating how the well-being parameter, for thesample of 10 patients, varied during the course of the 4 weeks, whilethe patients exercised, received stimulation therapy and recorded theirwell-being scores 3867 using their companion devices (as describedearlier with reference to FIG. 16). The bar graph 3860 shows medianwell-being scores per week, calculated from the well-being scores of thesample of 10 patients, while the bar graphs 3865 show variation inwell-being scores for a number of patients (y-axis) reporting symptomsof nausea/abdominal pain at each week. As can be observed from the bargraph 3860, the median well-being scores 3862, 3863, 3864, 3866 remainedstable during the first, second, third and fourth weeks relative to themedian well-being score 3861 at the baseline (that is, prior toreceiving stimulation therapy) although there were occasionaldeterioration of well-being scores per week (such as the well-beingscores 3868, 3869, 3870 for 4, 2 and 3 patients respectively) for somepatients, as can be observed from the bar graphs 3865.

It should be appreciated that the pre-stimulation levels of theplurality of patient variables or parameters (such as, but not limitedto, weight, BMI (Body Mass Index), appetite, dietary compliance andwell-being) are measured using a scale (such as a VAS) at predefinedtimes of the day over a first predefined period of time (such as 4weeks, for example), and the post-stimulation levels of the patientvariables or parameters are measured, after stimulation is initiated,using the scale at the predefined times of the day over a secondpredefined period of time, equal in duration to the first predefinedperiod of time.

It should be appreciated that each of the pre-stimulation andpost-stimulation levels, profiles or measurements may be assessed bycomparing data from a single individual or by first aggregatingpre-stimulation data from multiple individuals and post-stimulation datafrom multiple individuals and comparing the two aggregated data sets.Additionally, it should be appreciated that the effects of stimulationmay be assessed by comparing measured parameters, as described above,from either an individual or group (in the form of aggregated data) to acontrol individual or group which has not undergone stimulation. In suchcases, one would be comparing post-stimulation effects to no stimulationin a different individual or group of individuals (control) as opposedto comparing post-stimulation effects to pre-stimulation measurementsfrom the same individual or group of individuals.

FIG. 39 is a side view of an EDP device in accordance with anon-preferred embodiment. The EDP device 3900 has all electronics 3902,power 3901, a power transfer mechanism 3903, such as a coil, andelectrode 3904 captured within a single unit structure. The EDP device3900 contains one electrode 3904, in the form of a very fine wire thatpasses through the cutaneous tissue (skin) to reach the dermatome. Thewire is completely coated with an electrical insulator except for thedistal end where it is open to create an electrode. This portion isdesigned to be inserted into or near the dermatome of interest.

The EDP device 3900 is intended to be placed on, and adhered to, theskin over a dermatome of interest. The device 3900 can have differentshapes and sizes for different body types. Placement can be accomplishedvia a biocompatible adhesive on its surface, 3905, a band, a belt, orother such fixturing methods. The proper location of the electrode 3904may be determined by a sensing mechanism. This sensing mechanism can befeedback from the patient, an electronic sensing mechanism (e.g.,biopotential amplifier with analog filtering), or both. Once the properlocation is found, the patient can be tattooed to mark the spot forfuture device placements.

FIG. 40 is another non-preferred embodiment for an EDP device wherebyelectrodes are fully implanted. The target dermatome(s) are stimulatedthrough a small structure 4005 that has a plurality of anodes and aplurality of cathodes and is placed in the subcutaneous region 4006 of apatient's body 4007 proximate the target dermatome(s). This structure4005 also has a receiving mechanism to receive power from outside thepatient's body 4007. Power is transferred to structure 4005 from the EDPdevice 4000 which contains a battery 4001, electronics 4002, a powertransfer mechanism 4003, such as a coil. The EDP device 4000 is placedwith its bottom surface 4004 in close proximity to said subcutaneousregion 4006 to enable transfer of power from power transfer mechanism4003 to structure 4005.

FIG. 41 is another non-preferred embodiment for an EDP device wherebythe electrodes 4105 are not part of the main device housing. The targetdermatome(s) are stimulated through these electrodes 4105, which areoperably connected to the EDP device 4100 via a cable 4104. The cable4104 can either be permanently connected to the device 4100 ordetachable. The electrodes can be either cutaneous, percutaneous, or acombination of both. It should be understood that other portions of thedevice 4100 could be detachable as well. For example, the unit could beconstructed such that the power source 4101 and electrodes 4105 are bothdetachable. This would make the electronics 4102 a reusable element ofthe device 4100 while the power source 4101 and electrodes 4105 can bedisposable. Other such configurations can be envisioned. Optionally, thedevice 4100 also includes a power transfer mechanism, such as a coil. Abottom surface 4103 of the device includes an adhesive for securing thedevice 4100 to a skin surface of a patient.

FIG. 42 is another non-preferred embodiment for an EDP device 4200whereby there are no electrodes disposed on the surface of the deviceand only one percutaneous element 4203 that extends outward from thesurface of the device. The device 4200 contains a battery 4201,electronics 4202 and, optionally, a power transfer mechanism. Thisembodiment allows for a plurality of electrodes to be on thepercutaneous element 4203. A bottom surface 4204 of the device includesan adhesive for securing the device 4200 to a skin surface of a patient.

FIG. 43 is an embodiment of the percutaneous element 4203 of FIG. 42.The element 4203 has four electrodes 4301 connected to four pads 4305via conductors 4302. The element substrate 4303 can be made from aflexible material such as Kapton® (polyimide film) or other suchmaterial, and the electrodes 4301 and traces can be made of gold,platinum, etc. An insulate material such as polyimide or parylene can beused to prevent short circuiting of the electrode conductors in tissue.

Referring now to FIG. 44, shown is a block diagram of a system 4400 inaccordance with a non-preferred embodiment. System 4400 may be includedin, for example, a mobile computing node such as a cellular phone,smartphone, tablet, Ultrabook®, notebook, laptop, personal digitalassistant, and mobile processor based platform. However, in otherembodiments portions thereof may be included in the electronics of thedevices of FIGS. 39-42 (e.g., leaving out one of the two cores, thekeyboard, and the like).

Shown is a multiprocessor system 4400 that includes a first processingelement 4470 and a second processing element 4480. While two processingelements 4470 and 4480 are shown, it is to be understood that anembodiment of system 4400 may also include only one such processingelement. System 4400 is illustrated as a point-to-point interconnectsystem, wherein the first processing element 4470 and second processingelement 4480 are coupled via a point-to-point interconnect 4450. Itshould be understood that any or all of the interconnects illustratedmay be implemented as a multi-drop bus rather than point-to-pointinterconnect. As shown, each of processing elements 4470 and 4480 may bemulticore processors, including first and second processor cores (i.e.,processor cores 4474 a and 4474 b and processor cores 4484 a and 4484b). Such cores 4474 a, 4474 b, 4484 a, 4484 b may be configured toexecute instruction code in a manner similar to methods discussedherein.

Each processing element 4470, 4480 may include at least one sharedcache. The shared cache may store data (e.g., instructions) that areutilized by one or more components of the processor, such as the cores4474 a, 4474 b and 4484 a, 4484 b, respectively. For example, the sharedcache may locally cache data stored in a memory 4432, 4434 for fasteraccess by components of the processor. In one or more embodiments, theshared cache may include one or more mid-level caches, such as level 2(L2), level 3 (L3), level 4 (L4), or other levels of cache, a last levelcache (LLC), and/or combinations thereof.

While shown with only two processing elements 4470, 4480, it is to beunderstood that the scope of the present specification is not solimited. In other embodiments, one or more additional processingelements may be present in a given processor. Alternatively, one or moreof processing elements 4470, 4480 may be an element other than aprocessor, such as an accelerator or a field programmable gate array.For example, additional processing element(s) may include additionalprocessors(s) that are the same as a first processor 4470, additionalprocessor(s) that are heterogeneous or asymmetric to first processor4470, accelerators (such as, e.g., graphics accelerators or digitalsignal processing (DSP) units), field programmable gate arrays, or anyother processing element. There can be a variety of differences betweenthe processing elements 4470, 4480 in terms of a spectrum of metrics ofmerit including architectural, micro-architectural, thermal, powerconsumption characteristics, and the like. These differences mayeffectively manifest themselves as asymmetry and heterogeneity amongstthe processing elements 4470, 4480. For at least one embodiment, thevarious processing elements 4470, 4480 may reside in the same diepackage.

First processing element 4470 may further include memory controllerlogic (MC) 4472 and point-to-point (P-P) interfaces 4476 and 4478.Similarly, second processing element 4480 may include a MC 4482 and P-Pinterfaces 4486 and 4488. MC's 4472 and 4482 couple the processors torespective memories, namely a memory 4432 and a memory 4434, which maybe portions of main memory locally attached to the respectiveprocessors. While MC logic 4472 and 4482 is illustrated as integratedinto the processing elements 4470, 4480, for alternative embodiments theMC logic may be discreet logic outside the processing elements 4470,4480 rather than integrated therein.

First processing element 4470 and second processing element 4480 may becoupled to an I/O subsystem 4490 via P-P interfaces 4476, 4486 via P-Pinterconnects 4462, 4404, respectively. As shown, I/O subsystem 4490includes P-P interfaces 4494 and 4498. Furthermore, I/O subsystem 4490includes an interface 4492 to couple I/O subsystem 4490 with a highperformance graphics engine 4438. In one embodiment, a bus may be usedto couple graphics engine 4438 to I/O subsystem 4490. Alternately, apoint-to-point interconnect 4439 may couple these components.

In turn, I/O subsystem 4490 may be coupled to a first bus 4410 via aninterface 4496. In one embodiment, first bus 4410 may be a PeripheralComponent Interconnect (PCI) bus, or a bus such as a PCI Express bus oranother third generation I/O interconnect bus, although the scope of thepresent invention is not so limited.

As shown, various I/O devices 4414, 4424 may be coupled to first bus4410, along with a bus bridge 4418 which may couple first bus 4410 to asecond bus 4420. In one embodiment, second bus 4420 may be a low pincount (LPC) bus. Various devices may be coupled to second bus 4420including, for example, a keyboard/mouse 4422, communication device(s)4426 (which may in turn be in communication with a computer network),and a data storage unit 4428 such as a disk drive or other mass storagedevice which may include code 4430, in one embodiment. The code 4430 mayinclude instructions for performing embodiments of one or more of themethods described above. Further, an audio I/O 4424 may be coupled tosecond bus 4420.

Note that other embodiments are contemplated. For example, instead ofthe point-to-point architecture shown, a system may implement amulti-drop bus or another such communication topology. Also, theelements of FIG. 44 may alternatively be partitioned using more or fewerintegrated chips than shown in the FIG. 44.

FIG. 45 is another non-preferred embodiment of an EDP device 4500,whereby there are no active electronics incorporated. Instead, anantenna 4505 is connected to a simple passive rectifier circuit 4502 toconvert an RF signal 4511 to energy that is delivered to the electrodes4503 and 4504. The antenna 4505 can be of various designs, such as adipole antenna, inverted-F antenna, fractal antenna, or other suchantenna that can efficiently receive the transmitted RF power. Anexternal wireless device 4510 transmits the RF signal 4511 to the EDPdevice 4500. It should be appreciated that wireless energy, in the formof electromagnetic energy, RF energy, ultrasound energy, or anycombination thereof, is transferred from the external wireless device4510 (such as a smartphone, for example) to the EDP device 4500. Anembodiment can use a half-wave rectifier, a full-wave rectifier, or anyother passive rectifier circuits known in the art, for the passiverectifier circuit. An embodiment can have one antenna 4505 or anadditional second antenna 4506 to account for RF signal polarization.The electrodes 4503, 4504 can be percutaneous and/or skin surfaceelectrodes. An embodiment would contain sufficient electronicintelligence to avoid unintended stimulation from another externalwireless device, whether that be another patient controller or someother wireless device; e.g., airport security scanner, etc. Suchintelligence can be in the form of reading a specific data packetencoded in the RF transmission by means of modulation, such as amplitudemodulation, frequency shift keying modulation, or other suchconventional techniques.

An embodiment for an external wireless device 4510 is a battery poweredportable device. An embodiment for the external wireless device can be asmartphone or any other commercially-available mobile electronicsplatform (such as that shown in FIG. 44). An embodiment can include anattachment 4512 to a smartphone or commercially-available mobileelectronics platform which includes one or more of the following: anantenna, an RF signal generator circuit, an RF communication circuit,and an additional portable power source (e.g., battery). An embodimentfor the external wireless device can be portable, thereby incorporatinga portable power source. An embodiment for the external wireless devicecan be non-portable, thereby not requiring a portable power source andable to rely on the use of AC mains (connection to electrical wallsocket). An embodiment includes the ability to encode data in the RFtransmission to enable pairing to a desired EDP device only.

FIG. 46 is another non-preferred embodiment similar to that of FIGS. 40and 45 combined. More specifically, the EDP device 4605 has theelectrodes, antenna, and rectifier circuit fully implanted. The targetdermatome(s) are stimulated through this small structure that has aplurality of anodes and a plurality of cathodes and is placed in thesubcutaneous region 4606 of patient's body 4607 proximate the targetdermatome(s). Wireless energy 4601, in the form of electromagneticenergy, RF energy, ultrasound energy, or any combination thereof, istransferred from an external wireless device 4600 with embodiments asdescribed in FIG. 45.

Telemedicine

As discussed earlier, the electro-dermal patch device is in datacommunication with and controlled by the companion device. The companiondevice is further capable of being in data communication with one ormore remote patient care facilities and/or patient care personnelenabling telehealth or e-health and therefore allowing health careprofessionals to evaluate, diagnose and treat patients in remotelocations using telecommunications technology.

In accordance with an aspect of the present specification, the user'splurality of health related information, such as the user's hungerprofile, standard eating and meals profile, actual eating and mealsprofile, energy balance, weight trends, glucose data, will power levels,daily or periodic scores related to hunger, appetite, exercise andwell-being, daily or periodic composite scores, stimulation inducednausea, dyspepsia and habituation events, including stimulationprotocols, setting and parameters are recorded, archived and stored bythe Health Management application software on the Cloud (for example).In various embodiments, such recorded and archived health relatedinformation as well as stimulation protocols, settings and parameters ofthe user are communicated to one or more remote care facilities,healthcare industry participants such as insurance companies and/orpatient care personnel in real time, on-demand and/or periodically.

This enables the user to communicate his health status, trends,treatment or therapy details as well as therapeutic outcomes to theremote care facility and/or patient care personnel for evaluation,advice, support and further treatment and/or medication options. Forexample, weight loss programs focused on diets often fail due to weightgain after the termination of the program. However, the HealthManagement application software, which may be HIPAA compliant, enablescontinuous weight maintenance by: enabling remote monitoring of theuser's weight, blood glucose, blood pressure, and overall activitylevel, for example; supporting a plurality of modes of communicationsuch as, but not limited to, video-conferencing, tele-conferencing,email, and chat to enable interactive, real-time and/or asynchronousweight maintenance related advice or stimulation regimen for the user.For example, the user's nutrition specialist, fitness trainer and/or aconcierge service associated with the EDP device and Health Managementapplication of the present specification may access, process and analyzethe user's health related information and provide interventions in theform of adjusted or modified stimulation parameters, settings andprotocols; modifications to exercising routines, forms, frequency andperiod; and/or adjustments to the user's dietary plan.

Hydrolysis of Adipose Tissues

In accordance with an aspect, stimulation of the somatovisceral reflexusing the EDP device of the present specification allows for innervationof white adipose tissue to hydrolyze them. Even after losing weight,there are spots or areas that remain with a high amount of adiposetissue (for example hip or upper arm or love handles on the trunk). Insome embodiments, these spots or areas are stimulated over long periodsof time, for example daily, to hydrolyze the adipose tissue accumulatedin these spots or areas.

The above examples are merely illustrative of the many applications ofthe methods and systems of present specification. Although only a fewembodiments of the present invention have been described herein, itshould be understood that the present invention might be embodied inmany other specific forms without departing from the spirit or scope ofthe invention. Therefore, the present examples and embodiments are to beconsidered as illustrative and not restrictive, and the invention may bemodified within the scope of the appended claims.

We claim:
 1. A method for using an electrical dermal patch adapted to becontinuously worn by a patient, comprising: providing an electricaldermal patch comprising: a housing having a controller in electricalcommunication with a pulse generator; and at least two electrodesadapted to be adhered to the patient's skin and in electricalcommunication with the pulse generator, wherein the controller comprisesprogrammatic instructions that, when executed and transmitted to thepulse generator, cause the pulse generator to generate and transmit tothe at least two electrodes a first electrical stimulation pulse and asecond electrical stimulation pulse, wherein the first electrical pulseis defined by a first phase having a first polarity and a second phasehaving a second polarity that is opposite the first polarity, whereinthe second electrical pulse follows the first electrical pulse and isdefined by a third phase having a third polarity and a fourth phasehaving a fourth polarity that is opposite the third polarity, andwherein the second polarity is equal to the third polarity, programmingthe controller such that each of the electrical stimulation pulsescomprises a pulse width in a range of 10 μsec to 10 msec, a pulseamplitude in a range of 100 μA to 100 mA, and a pulse frequency in arange of 1 Hz and 10,000 Hz; determining if the patient experiences achange in appetite as a result of an application of said first set ofelectrical stimulation pulses or said second set of electricalstimulation pulses to the patient's skin; and determining if the patientexperiences erythema, scaling, pruritus, folliculitis, or zintertrigo ata point where the two electrodes adhere to the patient's skin.
 2. Themethod of claim 1, wherein the second electrical pulse follows the firstelectrical pulse after a predetermined time interval.
 3. The method ofclaim 2 wherein the predefined time interval is in a range of 1 minuteto 10 minutes.
 4. The method of claim 1, wherein the first polarity ispositive, the second polarity is negative, the third polarity isnegative, and the fourth polarity is positive.
 5. The of claim 1,wherein the first polarity is negative, the second polarity is positive,the third polarity is positive, and the fourth polarity is negative. 6.The method of claim 1, wherein each of the at least two electrodescomprise a hypoallergenic conductive gel with at least one adhesivesurface.
 7. The method of claim 1, wherein the electrode does notcomprise imidazolidinyl urea or diazolidinyl urea.
 8. The method ofclaim 1, wherein the electrode comprises carboxymethylcellulose polymerand propylene glycol.
 9. The method of claim 1, wherein the at least oneadhesive surface is adapted to adhere to the patient's skin and have apeel strength in a range of 1.0 to 2.1 newtons.
 10. The method of claim1, wherein the at least one adhesive surface is adapted to adhere to thepatient's skin and have a total skin contact surface area in a range of2 cm² to 4 cm².
 11. The method of claim 1, wherein the at least twoelectrodes are positioned in a same plane parallel to the patient's skinand separated by an area of 0.05 cm² to 0.4 cm².
 12. The method of claim1, wherein an amplitude of the first phase, the second phase, the thirdphase, and the fourth phase are equal and wherein a pulse width of thefirst phase, the second phase, the third phase, and the fourth phase areequal.
 13. The electrical dermal patch of claim 1, wherein an amplitudeof the first phase and the fourth phase are equal, wherein a pulse widthof the first phase and the fourth phase are equal, an amplitude of thesecond phase and the third phase are equal, wherein a pulse width of thesecond phase and the third phase are equal, and wherein at least one ofthe amplitude and the pulse width of the first phase is different fromthe amplitude and pulse width of the second phase.
 14. The method ofclaim 1 wherein the first phase is defined by a waveform characterizedby a first period and a second period, wherein the first periodcomprises a first 10 μs of the waveform and the second period comprisesa remainder of the waveform and wherein said waveform is defined by amaximum amplitude during the first period and an amplitude less thansaid maximum amplitude during the second period.
 15. The method of claim14 wherein the maximum amplitude is in a range of 20 to 40 mA.
 16. Themethod of claim 14 wherein the maximum amplitude is in a range of 20 to40 mA and an average amplitude across said first period and secondperiod is in a range of 10 mA to 20 mA.
 17. The method of claim 1wherein the pulse generator has a maximum compliance voltage in a rangeof 40 volts to 60 volts.
 18. The method of claim 1 wherein at least oneof the first phase, second phase, third phase, and fourth phase isdefined by a waveform characterized by a first period, a second period,and a third period, wherein the first period comprises at least aportion of 0 to 10 μs of the waveform, the second period comprises atleast a portion of 10 μs to 100 μs of the waveform, and the third periodcomprises at least a portion of 100 μs to 200 μs of the waveform,wherein the first period is defined by a maximum amplitude and thesecond and third periods are defined by a remainder amplitude less thansaid maximum amplitude.
 19. The method of claim 18 wherein the maximumamplitude is in a range of 20 mA to 40 mA.
 20. The method of claim 18wherein, in the second period, a decay of the remainder amplitude isdefined by a first negative slope having a first magnitude and, in thethird period, a decay of said remainder amplitude is defined by a secondnegative slope having a second magnitude, wherein the first magnitude isless than the second magnitude.
 21. The method of claim 18 wherein anaverage of the maximum amplitude and the remainder amplitude is in arange of 10 mA to 20 mA.